FDA UDI
In Commercial Distribution
🇺🇸 United States
PermaLife™ Cell Culture Bag
DI: 10816203023664
·
Model: PL70K
·
ORIGEN BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PermaLife™ Cell Culture Bag
- Primary DI
- 10816203023664
- Version / Model
- PL70K
- Catalog Number
- PL70K
- Company Name
- ORIGEN BIOMEDICAL, INC.
- Labeler DUNS
- 625272232
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-06
- Public Version
- 1
- Public Version Date
- 2024-12-16
- Public Version Status
- New
- Public Device Record Key
- 674c8c6b-40e4-4588-92d2-686360dd3aec
Device Description
PermaLife Cell Culture Bag, 70ml, "K" Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPZ | Container, Frozen Donor Tissue Storage | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44904 | Blood/tissue storage/culture container | A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10816203023664 | GS1 |
Customer Contacts
- Phone
- +1-512-474-7278
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021702 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not re-use
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not resterilize