InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 12/55 Tube & - Freudenberg Medical, LLC

Duns Number:120981337

Device Description: Post-Operative Care Kit with 12/55 Tube & ClassicFlow HME

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

InHealth Technologies; Blom-Singer

Version/Model Number

PK 2106

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

-

Product Code Details

Product Code

BYD

Product Code Name

Condenser, Heat And Moisture (Artificial Nose)

Device Record Status

Public Device Record Key

7bf87d2d-c59d-4cc7-98ee-370b8a66c837

Public Version Date

July 18, 2019

Public Version Number

1

DI Record Publish Date

July 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FREUDENBERG MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 193
2 A medical device with a moderate to high risk that requires special controls. 64
U Unclassified 24