Identity
- Trade Name
- Infinity FDA UDI
- Generic Name
- Personal device holder, reusable FDA UDI
- Device Name
- Enteralite Infinity Adult Pack, Black FDA UDI
- Model / Reference
- PCK4001 FDA UDI
- Description
- Enteralite Infinity Adult Pack, Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10814844001645 FDA UDI
- FDA Product Code
- LZH FDA UDI
- GMDN Term
- Personal device holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Personal device holder, reusable
Infinity by Zevex International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Personal device holder, reusable.
- TruLock — H R Pharmaceuticals, Inc. · Class I
- SJM™ — ST. JUDE MEDICAL, INC. · Class III
- Personal Device Holder — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Leg Bag Holder Small — FLEXICARE MEDICAL LIMITED · Class I
- CADD — ICU MEDICAL, INC. · Class II
- Kangaroo — Cardinalhealth · Class I
- Conveen — Coloplast A/S · Class I
- Axonics — AXONICS MODULATION TECHNOLOGIES, INC. · Class III
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
- Zevex International, Inc.
Sources (1)
- FDA UDI b0783e6f-a5d2-4efd-80df-bf8b7cfc5e4e 34 fields · synced Jun 8, 2026