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510(k) Data Aggregation
K Number
K980829Device Name
3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
Manufacturer
STERIPAK, LTD.
Date Cleared
1998-06-02
(90 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
STERIPAK, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For respiratory therapy and tracheal lavage
Device Description
The subject device is 3 mL Steri-Neb Saline, 0.9% "/v Sodium Chioride Inhalation Solution USP. Steri-Neb Saline is used for respiratory therapy and tracheal lavage. For respiratory therapy, Steri-Neb Saline is used for dilution of solutions used in nebulizers. Steri-Neb Saline is a unit dose low density polyethylene vial containing sterile, preservative-free, clear, colourless, aqueous solution. The Steri-Neb Saline product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
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K Number
K972185Device Name
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE
Manufacturer
STERIPAK, LTD.
Date Cleared
1998-03-05
(268 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
STERIPAK, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
20mL Normal Saline Topical Solution is usled for moistening and lubricating absorbent wound dressing prior to removal from the wound area.
Device Description
The subiect device is a 20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride. It is used for moistening and lubricating absorbent wound dressings prior to removal from the wound area. Normal Saline Topical Solution 0.9% w/v is a unit-dose low density polyethylene vial containing a. clear, colourless, aqueous solution. Normal Saline Topical Solution contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
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