Identity
- Trade Name
- Portex FDA UDI
- Generic Name
- Arterial blood sampling kit FDA UDI
- Model / Reference
- 4645P-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20351688005929 FDA UDI
- 510(k) Number
- K952516 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Arterial blood sampling kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
Yes
FDA UDI
Category: Arterial blood sampling kit
The Portex device is a sterile arterial blood sampling kit used for the collection of an arterial blood specimen directly from a patient. It features a needle, heparinized syringe, and other components designed to provide accurate and reliable results in clinical settings.
Similar devices
Also classified as Arterial blood sampling kit.
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- TRUWAVE/VAMP — Edwards Lifesciences LLC · Class II
- AirLife™ — Airlife, Inc. · Class I
- TRUWAVE, VAMP PLUS — Edwards Lifesciences LLC · Class II
- TRUWAVE, VAMP — Edwards Lifesciences LLC · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K952516 also covers:
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 3d8020a4-87cd-4a9c-9576-3c9a618a5e6a 33 fields · synced Jun 19, 2026