T PIECE -DOUBLE RING (OD:22mm/ID:19mm;OD:22mm/ID:15mm) - T PIECE -DOUBLE RING - BESMED HEALTH BUSINESS CORP.

Duns Number:658023775

Device Description: T PIECE -DOUBLE RING (OD:22mm/ID:19mm;OD:22mm/ID:15mm)

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More Product Details

Catalog Number

-

Brand Name

T PIECE -DOUBLE RING (OD:22mm/ID:19mm;OD:22mm/ID:15mm)

Version/Model Number

CT-13116

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

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Device Record Status

Public Device Record Key

6065e60d-3591-402a-ab45-b3399dd492c9

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

October 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BESMED HEALTH BUSINESS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 289
2 A medical device with a moderate to high risk that requires special controls. 217