O-Wrap™ Bag OW0909
GUDID 20816203023913
O-Wrap, overwrap pouch for freezing, 9x9cm
ORIGEN BIOMEDICAL, INC.
Blood/tissue storage/culture container| Primary Device ID | 20816203023913 |
| NIH Device Record Key | d342444b-fb89-4ca0-bd8e-533bf975f421 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O-Wrap™ Bag |
| Version Model Number | OW0909 |
| Catalog Number | OW0909 |
| Company DUNS | 625272232 |
| Company Name | ORIGEN BIOMEDICAL, INC. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816203023919 [Unit of Use] |
| GS1 | 10816203023916 [Primary] |
| GS1 | 20816203023913 [Package] Contains: 10816203023916 Package: Carton [50 Units] In Commercial Distribution |
FDA Product Code
| FMH | Container, Specimen, Sterile |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-26 |
| Device Publish Date | 2025-06-18 |
On-Brand Devices [O-Wrap™ Bag]
| 20816203024095 | O-Wrap, overwrap pouch for freezing, 9x18cm |
| 20816203023913 | O-Wrap, overwrap pouch for freezing, 9x9cm |
Trademark Results [O-Wrap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 O-WRAP 98492745 not registered Live/Pending |
OriGen Biomedical, Inc. 2024-04-10 |
 O-WRAP 78740496 3148588 Dead/Cancelled |
Visco, Anthony G. 2005-10-26 |
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