Identity
- Trade Name
- ASP MEDICAL FDA UDI
- Generic Name
- Ice bag FDA UDI
- Device Name
- BAG, ICE EYE, 4.5"X10", WITH CLOSURE, WHITE BAG WITH BLUE HOOK & LOOP STRAP, NON-WOVEN, SINGLE PATIENT USE, STICKER LABEL ON BAG WITH FILL LINE, LATEX-FREE, 15EA/BG, 2BG/CS (30EA/CS) FDA UDI
- Model / Reference
- IBA005 FDA UDI
- Description
- BAG, ICE EYE, 4.5"X10", WITH CLOSURE, WHITE BAG WITH BLUE HOOK & LOOP STRAP, NON-WOVEN, SINGLE PATIENT USE, STICKER LABEL ON BAG WITH FILL LINE, LATEX-FREE, 15EA/BG, 2BG/CS (30EA/CS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216107014 FDA UDI
- FDA Product Code
- KYR FDA UDI
- GMDN Term
- Ice bag FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ice bag
Asp Medical by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ice bag.
- HCS — Concordance Healthcare Solutions LLC · Class I
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- BIOS Living — Thermor Ltd · Class I
- VIVE — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- HCS — DYAD MEDICAL SOURCING, LLC · Class I
- HCS — DYAD MEDICAL SOURCING, LLC · Class I
- VIVE — VIVE HEALTH LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Asp Global, LLC
Sources (1)
- FDA UDI 8c414376-4aa2-4893-83ec-d624fc3a2545 33 fields · synced Jun 8, 2026