AllCare

FDA UDI

Class I (US FDA UDI)

by Allcare, Inc.

Identity

Trade Name: AllCare FDA UDI
Generic Name: Bed pillow, reusable FDA UDI
Device Name: LARGE PILLOW 17.5" X 20", LIGHT BLUE, DISPOSABLE FDA UDI
Model / Reference: PL300 FDA UDI
Description: LARGE PILLOW 17.5" X 20", LIGHT BLUE, DISPOSABLE FDA UDI

Identifiers

Primary DI / UDI-DI: 00182921000618 FDA UDI
FDA Product Code: KME FDA UDI
GMDN Term: Bed pillow, reusable 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bed pillow, reusable

AllCare by Allcare, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bed pillow, reusable.

DR-HOS — Guangzhou Xinbo Electronic Co., Ltd. · Class I
Big Wedge Pillow — Xiamen SeaWorld Houseware Co., Ltd. · N
DR-HOS — Guangzhou Xinbo Electronic Co., Ltd. · Class I
DMI — DMS HOLDINGS, INC., · Class I
ASP MEDICAL — Asp Global, LLC · Class I
Leg Elevation Pillow (CoolingGel) — Xiamen SeaWorld Houseware Co., Ltd. · N
Bed Wedge Pillow (7 inch) — Xiamen SeaWorld Houseware Co., Ltd. · N
DR-HOS — Guangzhou Xinbo Electronic Co., Ltd. · 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: Allcare, Inc.

Sources (1)

FDA UDI c19cf212-f732-4ba0-968d-bfd896f30ea5 35 fields · synced May 30, 2026