NIM Vital™ - PATIENT INTERFACE NIM4CPB1 NIM 4.0 - MEDTRONIC XOMED, INC.

Duns Number:835465063

Device Description: PATIENT INTERFACE NIM4CPB1 NIM 4.0

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More Product Details

Catalog Number

-

Brand Name

NIM Vital™

Version/Model Number

NIM4CPB1

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

K200759

Product Code Details

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Device Record Status

Public Device Record Key

67bb0cc2-27bc-488d-8288-771bb568985a

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC XOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 665
2 A medical device with a moderate to high risk that requires special controls. 1575
3 A medical device with high risk that requires premarket approval 6
U Unclassified 10