Identity
- Trade Name
- PremierPro™ FDA UDI
- Generic Name
- Intravenous line recessed-needle connector FDA UDI
- Device Name
- PremierPro™ by MedSource TrueSafe Comfort® Safety IV Catheter, 20G x 1.16in, 1 each FDA UDI
- Model / Reference
- 31T20116 FDA UDI
- Description
- PremierPro™ by MedSource TrueSafe Comfort® Safety IV Catheter, 20G x 1.16in, 1 each FDA UDI
Identifiers
- Catalog Number
- 31T20116 FDA UDI
- Primary DI / UDI-DI
- 00811220034528 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Intravenous line recessed-needle connector 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
Yes
FDA UDI
Category: Intravenous line recessed-needle connector
PremierPro™ by Svs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous line recessed-needle connector.
- Smith's Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
- MedSource TrueSafe Comfort Safety IV Catheter 18g 1.88" — MEDSOURCE INTERNATIONAL LLC · Class II
- MedSource Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
- Henry Schein Safety IV Catheter 20G x 1.88 — MEDSOURCE INTERNATIONAL LLC · Class II
- Smith's Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
- Smith's Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
- MedSource Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
- MedSource TrueSafe Safety IV Catheter 22g 1.00" — MEDSOURCE INTERNATIONAL 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
- Svs Llc
Sources (1)
- FDA UDI f348f266-95d6-4bf8-966b-bbaabb8725fc 35 fields · synced Jun 8, 2026