Identity
- Trade Name
- PS-84316 FDA UDI
- Generic Name
- Peripheral vascular/subcutaneous catheter FDA UDI
- Device Name
- 16g x 1.75” IV CATHETER PURSAFETY S FDA UDI
- Model / Reference
- PS-84316 FDA UDI
- Description
- 16g x 1.75” IV CATHETER PURSAFETY S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005864318 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Peripheral vascular/subcutaneous catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
No
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: Peripheral vascular/subcutaneous catheter
Ps-84316 by Pathen Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular/subcutaneous catheter.
- BASNWS -30/150 — PATHEN MEDICAL LLC · Class II
- PR-84220 — PATHEN MEDICAL LLC · Class II
- PS-843203 — PATHEN MEDICAL LLC · Class II
- PR-842202 — PATHEN MEDICAL LLC · Class II
- PR-84222 — PATHEN MEDICAL LLC · Class II
- BM-2135.17 — PATHEN MEDICAL LLC · Class II
- PS-843202 — PATHEN MEDICAL LLC · Class II
- PS-84320 — PATHEN MEDICAL LLC · Class II
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
- Pathen Medical Llc
Sources (1)
- FDA UDI 53c192a7-01ee-463f-9d3f-bec58813cfb4 34 fields · synced May 30, 2026