Identity
- Trade Name
- EXEL HIS ROTATING WING, NON-DEHP W/O Y 20GX3/4" FDA UDI
- Generic Name
- Subcutaneous infusion/injection port needle FDA UDI
- Device Name
- EXEL HIS ROTATING WING, NON-DEHP W/O Y 20GX3/4", 25/INNERBX, 50/BX, 20BX/CRTN FDA UDI
- Model / Reference
- 27955R FDA UDI
- Description
- EXEL HIS ROTATING WING, NON-DEHP W/O Y 20GX3/4", 25/INNERBX, 50/BX, 20BX/CRTN FDA UDI
Identifiers
- Catalog Number
- 27955R FDA UDI
- Primary DI / UDI-DI
- 00020221079555 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 His Rotating Wing, Non-Dehp W/O Y 20gx3/4" by Exel International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subcutaneous infusion/injection port needle.
- POLYPERF SAFE — PEROUSE MEDICAL · Class II
- Pure Comfort Safety Pen Needles 6MM 31G — HOME AIDE DIAGNOSTICS, INC. · Class II
- PPS PI — PEROUSE MEDICAL · Class II
- Pure Comfort Safety Pen Needles 4MM 32G — HOME AIDE DIAGNOSTICS, INC. · Class II
- PPS PI — PEROUSE MEDICAL · Class II
- POLYPERF SAFE — PEROUSE MEDICAL · Class II
- ProFusion — COOK INCORPORATED · Class I
- HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exel International
Sources (1)
- FDA UDI 7ffc3d28-99e0-47d1-beca-6177cdbe111f 35 fields · synced Jun 1, 2026