714-A iCrib - HARD MANUFACTURING CO., INC.

Duns Number:021899778

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More Product Details

Catalog Number

714-A

Brand Name

714-A iCrib

Version/Model Number

714-A

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)

Yes

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

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Device Record Status

Public Device Record Key

564160d0-7900-415f-9c58-6c1f667989fd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 17, 2017

Additional Identifiers

Package DI Number

00852231007842

Quantity per Package

1

Contains DI Package

00852231007835

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HARD MANUFACTURING CO., INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 63