AccessGUDID - DEVICE: DIACLEAR (07332414066314)

GUDID

Device Identifier (DI) Information

Brand Name: DIACLEAR
Version or Model: 106887
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 106887
Company Name: GAMBRO INDUSTRIES

Primary DI Number: 07332414066314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 393020474 *Terms of Use

Device Description: The DIACLEAR ultrafilter is intended to be used only with either HOSPAL Integra or Innova or GAMBRO Phonenix dialysis machines. It is indicated for purification of dialysis fluid to obtain microbiologically high quality dialysis fluid.

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":	Yes
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?
35072	Intravenous line filter	A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	SUBSYSTEM, WATER PURIFICATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003957	000

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
Special Storage Condition, Specify: Store in a dry place
Storage Environment Temperature: between 0 and 30 Degrees Celsius
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df402d02-62f8-489c-93e0-af4d91712868
Public Version Date: July 20, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016