Nova - NOVA BLANKET, UPPER BODY - Encompass Group, L.L.C.

Duns Number:121788819

Device Description: NOVA BLANKET, UPPER BODY NOVA BLANKET, UPPER BODY,70"W X 25"L, NOVA BLANKET, UPPER BODY NOVA BLANKET, UPPER BODY,70"W X 25"L,IND PKG,25 EA/CS

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More Product Details

Catalog Number

-

Brand Name

Nova

Version/Model Number

AW5100-200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

Yes

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

K203085,K203085

Product Code Details

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Device Record Status

Public Device Record Key

44782433-e7a5-4bfc-bd87-c11ae64f9991

Public Version Date

July 15, 2021

Public Version Number

1

DI Record Publish Date

July 07, 2021

Additional Identifiers

Package DI Number

50612899006480

Quantity per Package

25

Contains DI Package

00612899006485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"ENCOMPASS GROUP, 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 1
2 A medical device with a moderate to high risk that requires special controls. 112