ASEPT® - BARE ASEPT 1000ML BOTTLE W/O DRAIN LINE - B BRAUN INTERVENTIONAL SYSTEMS, INC

Duns Number:784259751

Device Description: BARE ASEPT 1000ML BOTTLE W/O DRAIN LINE

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More Product Details

Catalog Number

622273B

Brand Name

ASEPT®

Version/Model Number

622273B

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)

Yes

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

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Device Record Status

Public Device Record Key

13ffb10a-e0a2-492e-ae4a-55dd2982f57b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B BRAUN INTERVENTIONAL SYSTEMS, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1226
3 A medical device with high risk that requires premarket approval 361