Identity
- Trade Name
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 1" FDA UDI
- Generic Name
- Subcutaneous infusion/injection port needle FDA UDI
- Device Name
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 1"; 20PCS/BOX, 160PCS/CASE FDA UDI
- Model / Reference
- 37858S FDA UDI
- Description
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 1"; 20PCS/BOX, 160PCS/CASE FDA UDI
Identifiers
- Catalog Number
- 37858S FDA UDI
- Primary DI / UDI-DI
- 00020221078589 FDA UDI
- 510(k) Number
- K012879 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Subcutaneous infusion/injection port needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
Category: Subcutaneous infusion/injection port needle
Exel Safety+ His Fixed Wing, Non-Dehp 22g X 1" by Exel International — 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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- PPS PI — PEROUSE MEDICAL · Class II
- POLYPERF SAFE — PEROUSE MEDICAL · Class II
- ProFusion — COOK INCORPORATED · Class I
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Cleared under the same submission
K012879 also covers:
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP 20G X 1 1/2" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP 20G X 1" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP 20G X 3/4" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 3/4" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 19G X 1" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 19G X 3/4" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 20G X 1 1/2" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 20G X 1" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 20G X 3/4" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 22G X 1 1/2" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 22G X 1" — Exel International
- EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 22G X 3/4" — Exel International
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
- Exel International
Sources (1)
- FDA UDI 7e83c849-77b0-4983-8008-c270e91974c5 36 fields · synced May 30, 2026