ALLCARE - FLEECE BLANKET, HEAVYWEIGHT, MAROON, 60" X 90", - ALLCARE, INC

Duns Number:362187580

Device Description: FLEECE BLANKET, HEAVYWEIGHT, MAROON, 60" X 90", 10/Case

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More Product Details

Catalog Number

-

Brand Name

ALLCARE

Version/Model Number

EB500M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KME

Product Code Name

Bedding, Disposable, Medical

Device Record Status

Public Device Record Key

98db5a6c-059a-4dc0-8e63-785729900dc5

Public Version Date

March 15, 2022

Public Version Number

1

DI Record Publish Date

March 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALLCARE, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20