AllCare, INC

Basic Information

• Brand Name: AllCare, INC
• Primary DI: 00182921000533
• Version / Model: PL200
• Catalog Number: PL200
• Company Name: ALLCARE, INC
• Labeler DUNS: 362187580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-06
• Public Version: 3
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 363c2c2e-8a5a-44c9-8bae-8929c17bebca

Device Description

SMALL PILLOW, BLUE, 14" X 16", DISPOSABLE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KME	Bedding, Disposable, Medical	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15593	Bed pillow, reusable	A sealed fabric case (e.g., cotton, pure wool) stuffed with soft material (e.g., down, polyester, foam, buckwheat husks) designed to support the head especially during rest and sleep in bed; it can also be used to support another part of the body to provide comfort (e.g., behind the back when in a sitting position, under a leg for support). It may or may not be used with a pillowcase and is laundered for cleaning between periods of use. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites; it is not dedicated to specialized applications/therapies. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00182921000533	GS1
Package	10182921000530	GS1	CASE	15	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius