AccessGUDID - DEVICE: PermaLife (00816203021762)

GUDID

Device Identifier (DI) Information

Brand Name: PermaLife
Version or Model: PL120M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORIGEN BIOMEDICAL, INC.

Primary DI Number: 00816203021762
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 625272232 *Terms of Use

Device Description: PermaLife Cell Culture Bag, 120ml, with 10cm sheath

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):	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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Patient-washing mitten	A non-sterile device worn on the hand to wash a patient; it is commonly used by a caregiver to bathe an incapacitated patient. It is typically made of waterproof plastic materials and has a soft exterior surface that may be pre-treated with mild detergent (a soap). The device also serves as a barrier to help prevent cross-contamination between the patient and the caregiver. It is typically used in the intensive care unit (ICU), for oncology patients, and for long-term patients in a healthcare facility or at home. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Patient-washing mitten

A non-sterile device worn on the hand to wash a patient; it is commonly used by a caregiver to bathe an incapacitated patient. It is typically made of waterproof plastic materials and has a soft exterior surface that may be pre-treated with mild detergent (a soap). The device also serves as a barrier to help prevent cross-contamination between the patient and the caregiver. It is typically used in the intensive care unit (ICU), for oncology patients, and for long-term patients in a healthcare facility or at home. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
LPZ	Container, Frozen Donor Tissue Storage

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ebbc49d-0ad4-41c6-b558-ccc1373700f0
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 27, 2016