BED COVER-LINET AIR-8X35X85-POLYCARB - BED COVER-LINET AIR-8X35X85-POLYCARBONATE - CURBELL MEDICAL PRODUCTS, INC.

Duns Number:796452311

Device Description: BED COVER-LINET AIR-8X35X85-POLYCARBONATE

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More Product Details

Catalog Number

27260

Brand Name

BED COVER-LINET AIR-8X35X85-POLYCARB

Version/Model Number

BMC-LINET AIR-83585-PC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 16, 2022

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Device Record Status

Public Device Record Key

98cc998f-fb6b-4989-9418-5bc4b89a9f55

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

December 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CURBELL MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 478
2 A medical device with a moderate to high risk that requires special controls. 8062