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First PICC™ S/L Peripherally Inserted Central Catheter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- First PICC™ S/L Peripherally Inserted Central Catheter FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- First PICC™ S/L Peripherally Inserted Central Catheter 16ga (5F) 1.70mm x 65cm FDA UDI
- Model / Reference
- 384158 FDA UDI
- Description
- First PICC™ S/L Peripherally Inserted Central Catheter 16ga (5F) 1.70mm x 65cm FDA UDI
Identifiers
- Catalog Number
- 384158 FDA UDI
- Primary DI / UDI-DI
- 00886333209699 FDA UDI
- 510(k) Number
- K972262 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Peripherally-inserted central venous catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
First PICC™ S/L Peripherally Inserted Central Catheter by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 Medical Devices, Inc.
Sources (1)
- FDA UDI 90edcc73-f0c4-47fa-8705-6835bb60c30f 39 fields · synced Jun 9, 2026