G Series NPT3 Mattress Family - SIZEWISE RENTALS, L.L.C.

Duns Number:967025602

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More Product Details

Catalog Number

-

Brand Name

G Series NPT3 Mattress Family

Version/Model Number

G Series NPT3 Mattress Family

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Device Record Status

Public Device Record Key

d103af87-c48e-4794-9b7c-20b6c2e9cbf5

Public Version Date

March 10, 2021

Public Version Number

1

DI Record Publish Date

March 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIZEWISE RENTALS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 130
2 A medical device with a moderate to high risk that requires special controls. 139