DEVICE: PermaLife (00816203021762)
Device Identifier (DI) Information
PermaLife
PL120M
In Commercial Distribution
ORIGEN BIOMEDICAL, INC.
PL120M
In Commercial Distribution
ORIGEN BIOMEDICAL, INC.
PermaLife Cell Culture Bag, 120ml, with 10cm sheath
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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. |
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3ebbc49d-0ad4-41c6-b558-ccc1373700f0
March 29, 2018
2
May 27, 2016
March 29, 2018
2
May 27, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10816203021769 | 10 | 00816203021762 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
512-474-7278
regulatory@origen.com
regulatory@origen.com