E.M. Adams Co, Inc. - SAFETY VEST - E.M. ADAMS, INC.

Duns Number:001403807

Device Description: SAFETY VEST

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More Product Details

Catalog Number

-

Brand Name

E.M. Adams Co, Inc.

Version/Model Number

EP90612S-1

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K971948,K971948

Product Code Details

Product Code

FMQ

Product Code Name

Restraint, Protective

Device Record Status

Public Device Record Key

536a9d51-bf0d-4c22-874b-ad6743c1dcda

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 13, 2022

Additional Identifiers

Package DI Number

50840200324477

Quantity per Package

24

Contains DI Package

10840200324486

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"E.M. ADAMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1447
2 A medical device with a moderate to high risk that requires special controls. 11