AccessGUDID - DEVICE: Pall-Aquasafe™ Water Filter (05034480313690)

GUDID

Device Identifier (DI) Information

Brand Name: Pall-Aquasafe™ Water Filter
Version or Model: AQ31F1SA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AQ31F1SA
Company Name: Pall International Sàrl

Primary DI Number: 05034480313690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 485050483 *Terms of Use

Device Description: 0.2 micron Water Filter - Faucet - for 31 day use

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:	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?
58088	Microbial water purification filter, non-sterilizable	A sterile device designed to remove bacteria and other suspended particles from flowing water by creating a mechanical barrier to elements larger than 0.2 micrometres. It typically consists of a plastic housing with a connector to the water source [e.g., a tap (faucet)] and a 0.2 micrometre filtering membrane [e.g., made of nylon, polyvinylidene fluoride (PVDF), or polyethersulfone (PES)]; a prefiltration of the water to remove larger particles is typically recommended. It is typically used for hygienic and surgical hand washing, wound irrigation, and/or rinsing of medical devices. This is a disposable, non-sterilizable device which may serve multiple patients before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHV	SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153434	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Pore Size: 0.2 Micrometer

Device Record Status

Public Device Record Key: caa5c396-6eba-4b98-b383-d34405f69c60
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 20, 2016