DEVICE: PermaLife (00816203021762)

Device Identifier (DI) Information

PermaLife
PL120M
In Commercial Distribution

ORIGEN BIOMEDICAL, INC.
00816203021762
GS1

1
625272232 *Terms of Use
PermaLife Cell Culture Bag, 120ml, with 10cm sheath
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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.
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FDA Product Code

[?]
Product Code Product Code Name
LPZ Container, Frozen Donor Tissue Storage
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3ebbc49d-0ad4-41c6-b558-ccc1373700f0
March 29, 2018
2
May 27, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
512-474-7278
regulatory@origen.com
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