AccessGUDID - DEVICE: Diacap® (04039239090496)

GUDID

Device Identifier (DI) Information

Brand Name: Diacap®
Version or Model: 7107367
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7107367
Company Name: B.Braun Avitum AG

Primary DI Number: 04039239090496
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2024
Device Count: 6
Labeler D-U-N-S® Number*: 343689704 *Terms of Use

Device Description: Diacap® Ultra Dialysis Fluid Filters

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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
47739	Haemodialysis system dialysate pyrogen filter	A sterile device designed to be used with a haemodialysis system for filtration of dialysate during haemodialysis to remove bacteria and endotoxins and produce purified dialysate for the procedure. It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis. It typically consists of a plastic housing, containing a hollow fibre membrane, with appropriate connectors at either end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FKQ	SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 0 and 30 Degrees Celsius
Special Storage Condition, Specify: Fragile, handle with care
Special Storage Condition, Specify:
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9abc5d14-000b-4e0b-a4c9-b2ba26d8811f
Public Version Date: June 03, 2024
Public Version Number: 6
DI Record Publish Date: August 09, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 04039239090489 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)848-2066
Email: rtd.us@bbraun.com

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