Identity
- Trade Name
- Pulset FDA UDI
- Generic Name
- Arterial blood sampling kit FDA UDI
- Device Name
- Full Kit, Pulset 1cc Syringe 25g x 5/8" (.5 x 15.9mm) Q-Cork, 25u Balanced Heparin FDA UDI
- Model / Reference
- 3173-14 FDA UDI
- Description
- Full Kit, Pulset 1cc Syringe 25g x 5/8" (.5 x 15.9mm) Q-Cork, 25u Balanced Heparin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078009082 FDA UDI
- FDA Product Code
- CBT FDA UDI
- GMDN Term
- Arterial blood sampling kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Arterial blood sampling kit
The Pulset Arterial Blood Sampling Kit is a comprehensive medical device designed to obtain an arterial blood specimen directly from patients, providing critical information for diagnosing and treating various medical conditions. This single-use kit includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label.
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Also classified as Arterial blood sampling kit.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Westmed, Inc.
Sources (1)
- FDA UDI 38b4a726-28b0-4bd6-9c24-9aafd0b2ee21 33 fields · synced Jun 24, 2026