Identity
- Trade Name
- POLYPERF SAFE FDA UDI
- Generic Name
- Subcutaneous infusion/injection port needle FDA UDI
- Model / Reference
- U112006 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661234014156 FDA UDI
- 510(k) Number
- K063631 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Subcutaneous infusion/injection port needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
No
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
MR Conditional FDA UDI
Category: Subcutaneous infusion/injection port needle
Polyperf Safe by Perouse Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Subcutaneous infusion/injection port needle.
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- Easy Comfort Safety Pen Needles 31G 5mm — HOME AIDE DIAGNOSTICS, INC. · Class II
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC. · Class II
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC. · Class II
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC. · Class II
Cleared under the same submission
K063631 also covers:
- POLPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
- POLYPERF SAFE — PEROUSE MEDICAL
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
- Perouse Medical
Sources (1)
- FDA UDI f40a390b-ae37-4dde-aab3-a3e3bc5d3534 33 fields · synced May 31, 2026