Bedal - Non Sterilized - Bedal

Duns Number:370066406

Device Description: Non Sterilized

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More Product Details

Catalog Number

PCNS02

Brand Name

Bedal

Version/Model Number

bedal picc/cvc

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

KGZ

Product Code Name

Accessories, Catheter

Device Record Status

Public Device Record Key

7a6b5bf4-8f9d-4baf-9d58-96ee4c5ca52c

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Additional Identifiers

Package DI Number

05430000258531

Quantity per Package

75

Contains DI Package

00543000025524

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BEDAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8