Identity
- Trade Name
- SAFEDRAW(TM) TA4812SD FDA UDI
- Generic Name
- Arterial blood sampling kit FDA UDI
- Device Name
- A Safedraw Septum connected to a 3cc Restricted Syringe stops at 2cc via a 48” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set. FDA UDI
- Model / Reference
- 682136 FDA UDI
- Description
- A Safedraw Septum connected to a 3cc Restricted Syringe stops at 2cc via a 48” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set. FDA UDI
Identifiers
- Catalog Number
- 682136 FDA UDI
- Primary DI / UDI-DI
- 00886333621361 FDA UDI
- FDA Product Code
- DSK FDA UDI
- GMDN Term
- Arterial blood sampling kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Arterial blood sampling kit
Safedraw(tm) Ta4812sd by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Argon Critical Care Systems Singapore Pte. Ltd.
Sources (1)
- FDA UDI 40c23ba4-7d2e-4a0c-aa7d-8823a774b121 36 fields · synced Jun 8, 2026