Vas-Cath - Probe Cover, 96" (10PK) NT - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: Probe Cover, 96" (10PK) NT

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More Product Details

Catalog Number

2683796

Brand Name

Vas-Cath

Version/Model Number

2683796

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

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Device Record Status

Public Device Record Key

ad8cc9c8-f3aa-419b-90ba-a8bd9db506a2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

20801741041550

Quantity per Package

12

Contains DI Package

10801741041553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"BARD ACCESS SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 3348
U Unclassified 8