Search Results
Found 1 results
510(k) Data Aggregation
K Number
K060672Device Name
ONE STICK Y EXTENSION SET AND VOLUMETER
Manufacturer
Date Cleared
2006-03-31
(17 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
ONE STICK LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FOR 7th Collections AND Ax بي جي جي هم INDICATED OF White -17-11-17 Blours SPECIMIANS Priva 70 FURTHER TESTING
The One Stick™ Volumeters™ and Y-Set families are indicated for the collection and handling of blood specimens prior to further testing.
Device Description
One Stick" Volumeters™ and Y-Set family of sets are supplied as sterile devices, and are intended for single patient use only. They are available in 3cc and 5cc sizes and are manufactured per cGMP Standards. The Y sets are comprised of standard components currently on the market. The Y sets are currently covered by 510(k) K051499. The barrel of the Volumeter™ is currently marketed by Becton Dickinson in their 3ml syringe. The Vent cap is molded with Class VI polypropylene, silicone O-ring and a Gore expanded PTFE supported membrane.
The One Stick™ Device is a blood collection assistance device for drawing samples from patients with suboptimal blood flow for standard procedures (Elderly and pediatric patients, those patients that may experience blood vessel collapse or excessive hemolysis when conventional Vacutainers are used directly). The device consists of a male luer fitting for attaching to a venipuncture, a section of tubing connecting the luer to a Y-Connector with a Roberts clamp for interrupting flow, two additional sections of tubing attached to needless access devices. This Y device is then attached to a vented volume collection tube.
Ask a Question
Ask a specific question about this device
Page 1 of 1