Transcend - SOMNETICS INTERNATIONAL, INC.

Duns Number:047069263

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More Product Details

Catalog Number

505004

Brand Name

Transcend

Version/Model Number

AirFlex Micro 6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Device Record Status

Public Device Record Key

13da5715-d2c5-4f98-b58a-8899822116d9

Public Version Date

August 11, 2022

Public Version Number

1

DI Record Publish Date

August 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOMNETICS INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 32