Alleset - Bariatric Mattress - GRI Medical & Electronic Technology Co., Ltd.

Duns Number:679894738

Device Description: Bariatric Mattress Cover_49inX81in_Bulk_N/S_12EA/CS

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More Product Details

Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model BM4880-COVER

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

Yes

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

f013fd5c-d7a7-42d8-9fb0-99b50b386477

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 185
2 A medical device with a moderate to high risk that requires special controls. 295