n/a - Nocturnal Patient Kit - SALTER LABS

Duns Number:022721133

Device Description: Nocturnal Patient Kit

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More Product Details

Catalog Number

SO-1910-0

Brand Name

n/a

Version/Model Number

SO-1910-0

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"

Yes

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

CAT

Product Code Name

CANNULA, NASAL, OXYGEN

Device Record Status

Public Device Record Key

d1002c7e-926f-4841-a265-d0dd3300da1d

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

November 30, 2016

Additional Identifiers

Package DI Number

10607411981958

Quantity per Package

10

Contains DI Package

00607411981951

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SALTER LABS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 865
2 A medical device with a moderate to high risk that requires special controls. 1134