Identity
- Trade Name
- ALLCARE FDA UDI
- Generic Name
- Basic bed sheet, single-use FDA UDI
- Device Name
- DISPOSABLE HEAVY DUTY FITTED SHEET 30" X 72" WHITE FDA UDI
- Model / Reference
- EF800 FDA UDI
- Description
- DISPOSABLE HEAVY DUTY FITTED SHEET 30" X 72" WHITE FDA UDI
Identifiers
- Catalog Number
- EF800 FDA UDI
- Primary DI / UDI-DI
- 10182921000691 FDA UDI
- FDA Product Code
- KME FDA UDI
- GMDN Term
- Basic bed sheet, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6060 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
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic bed sheet, single-use
Allcare by Allcare, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic bed sheet, single-use.
- HUANFU — Hubei Huanfu Plastic Products Co., Ltd. · Class I
- Curaplex® — BOUND TREE MEDICAL, LLC · Class I
- AMXOR Essentials Disposable Exam Table Paper Roll — Amxor Healthcare LLC · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
- MedSource Sheet — MEDSOURCE INTERNATIONAL LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- MedSource Sheet — MEDSOURCE INTERNATIONAL 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Allcare, Inc.
Sources (1)
- FDA UDI c65684ea-15f7-4b82-9075-bb2691195a63 36 fields · synced Jun 1, 2026