AccessGUDID - DEVICE: ASEPT® (04046964717765)

GUDID

Device Identifier (DI) Information

Brand Name: ASEPT®
Version or Model: 622272B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 622272B
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964717765
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: BARE ASEPT 600ML BOTTLE W/O DRAIN LINE

Device Characteristics

What MRI safety information does the labeling contain?	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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35824	Closed-wound drainage kit	A collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	BOTTLE, COLLECTION, VACUUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY
Special Storage Condition, Specify: Store at room temp
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 600.0 Milliliter

Device Record Status

Public Device Record Key: 0c05a427-1259-41bc-b4dc-519fd9a8d0a0
Public Version Date: September 07, 2023
Public Version Number: 5
DI Record Publish Date: August 09, 2016