TIMM - Gas tubing kit - MEDIPLUS LTD

Duns Number:228480810

Device Description: Gas tubing kit

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More Product Details

Catalog Number

-

Brand Name

TIMM

Version/Model Number

TIMM21188

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

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

-

Product Code Details

Product Code

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Device Record Status

Public Device Record Key

61405a00-d95e-41b4-9130-d9737b63a729

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

15055140703399

Quantity per Package

25

Contains DI Package

05055140703392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDIPLUS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 95