Halyard - Pillowcase, Blue - O&M HALYARD, INC.

Duns Number:081057389

Device Description: Pillowcase, Blue

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More Product Details

Catalog Number

67803

Brand Name

Halyard

Version/Model Number

67803

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"

-

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

KME

Product Code Name

BEDDING, DISPOSABLE, MEDICAL

Device Record Status

Public Device Record Key

0e74686f-47d5-489d-a8dd-6bd9c84931f7

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

December 31, 2020

Additional Identifiers

Package DI Number

30680651678035

Quantity per Package

1

Contains DI Package

20680651678038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"O&M HALYARD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 1044