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510(k) Data Aggregation
K Number
K240961Device Name
Disposable Pen Injector Assembly
Manufacturer
Date Cleared
2024-08-15
(129 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Wuxi NEST Biotechnology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1 unit increments. It is intended for general population.
Device Description
The Disposable Pen Injector Assembly is a disposable single-patient use pen injector capable of injecting a dose of up to 80 units of insulin in 1 unit increments. The pen injector is intended for use with 3mL insulin cartridges and single-use, disposable insulin pen needles (supplied separately). After the intended insulin cartridge is used up, the Disposable Pen Injector Assembly should be disposed. The Disposable Pen Injector Assembly is intended for single user only and provided non-sterile.
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K Number
K240774Device Name
Pen Injector
Manufacturer
Date Cleared
2024-06-18
(89 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Wuxi NEST Biotechnology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pen Injector is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The Pen Injector uses HUMALOG (insulin lispro) injection (U-100) available in 3 mL cartridges, and a single use detachable and disposable insulin pen needle (supplied separately, needle sizes including: 32G*4mm, 31G*4mm, 31G*5mm, and 31G*6mm).
Device Description
The Pen Injector is a reusable mechanical pen-injector capable of injecting a dose of up to 80 units of insulin, in 1 unit increments. The Pen Injector consists of a pen injector body, a push block, a injection button, a dose display window, a dose adjustment knob, a reservoir and a pen injector cap. The intended dose is mechanically set by rotating a dose adjustment knob. The insulin is injected by depressing the knob which mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The Pen Injector is intended for single user and provided for non-sterile.
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K Number
K211256Device Name
Disposable Sampler Viral Transport Media
Manufacturer
Date Cleared
2022-05-20
(389 days)
Product Code
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
Wuxi Nest Biotechnology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NEST Disposable Sampler (Viral Transport Medium) is intended for the collection and transport of upper respiratory clinical specimens to the laboratory for standard diagnostic or identification techniques. The Viral Transport Medium can be used in the laboratory to perform culture, isolation and detection of upper respiratory viruses including Influenza A, Rhinovirus, and Respiratory Syncytial Virus (RSV).
Device Description
The Disposable Sampler Viral Transport Media is composed of preservation tubes filled with VTM (Viral Transport Media), kitted with or without swabs, depending on the product type. The Disposable Sampler Viral Transport Media is composed of Sodium chloride, Disodium hydrogen phosphate dodecahydrate, Potassium chloride, Potassium dihydrogen phosphate, Magnesium sulfate heptahydrate, Glucose, HEPES, Sodium bicarbonate, Fluconazole, Gentamicin sulfate, Griseofulvin, Polymyxin sulfate, Phenol red (optional), Sodium hydroxide, Calcium chloride, Bovine serum albumin and L-Cysteine. The preservation tube is made of medical-grade polypropylene materials. For both oropharyngeal and nasopharyngeal swabs, the swab head is made of flocked nylon fiber, and the rod is made of ABS (acrylonitrile butadiene styrene).
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K Number
K210440Device Name
Disposable Sampler Inactivated Transport Media, Nest ITM
Manufacturer
Date Cleared
2021-09-20
(220 days)
Regulation Number
866.2950Why did this record match?
Applicant Name (Manufacturer) :
Wuxi Nest Biotechnology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NEST ITM is an enclosed system intended for the collection, inactivation stabilization and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from the collection site to the testing laboratory. The specimen transported in NEST ITM can be used for molecular detection in the laboratory.
Device Description
The NEST ITM is a medical-grade Polypropylene preservation tube (5 mL and 10 mL) filled with 2.5 mL ITM Inactivated Transport Media for 5 mL tube or 3 mL Inactive Transport Media for 10 mL tube, with or without the sterile swabs. NEST ITM is composed of Guanidine isothiocyanate, TCEP, sodium acetate, PEG-6000, Tris, Hcl, purified water in order to inactivate infectious unprocessed oropharyngeal and nasopharyngeal samples which are suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from human samples. For both oropharyngeal and nasopharyngeal swabs, the swab head is made of flocked nylon fiber, and the rod is made of ABS (acrylonitrile butadiene styrene).
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