AccessGUDID - DEVICE: PureLife+ Sterilization Pouches (D79011920051)

GUDID

Device Identifier (DI) Information

Brand Name: PureLife+ Sterilization Pouches
Version or Model: 1192005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1192005
Company Name: PURELIFE, LLC

Primary DI Number: D79011920051
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 828690904 *Terms of Use

Device Description: PureLife+ Sterilization Pouches, 5 1/4" x 10", Self-sealing sterilization pouches, Class 4 dual indicators, Thumb notch for easy opening

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:	Yes
Prescription Use (Rx):	No
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?
60908	Sterilization container liner	A non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRG	Wrap, sterilization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172280	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 75b07a2d-a622-4106-9e7b-c83938e7312b
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023