FDA UDI
Not in Commercial Distribution
🇺🇸 United States
O-Wrap™ Bag
DI: 10816203023916
·
Model: OW0909
·
ORIGEN BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- O-Wrap™ Bag
- Primary DI
- 10816203023916
- Version / Model
- OW0909
- Catalog Number
- OW0909
- Company Name
- ORIGEN BIOMEDICAL, INC.
- Labeler DUNS
- 625272232
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-06-18
- Public Version
- 2
- Public Version Date
- 2026-01-26
- Public Version Status
- Update
- Public Device Record Key
- d342444b-fb89-4ca0-bd8e-533bf975f421
- Distribution End Date
- 2026-01-23
Device Description
O-Wrap, overwrap pouch for freezing, 9x9cm
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
- Yes
- 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 |
|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | Pathology | 864.3250 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 20816203023913 | GS1 | Carton | 50 | Not in Commercial Distribution | 2026-01-23 |
| Primary | 10816203023916 | GS1 | ||||
| Unit of Use | 00816203023919 | GS1 |
Customer Contacts
- Phone
- +1-512-474-7278
- [email protected]
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