Accessories 15-RF12-T
GUDID 20816203023876
12ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
Blood transfer set| Primary Device ID | 20816203023876 |
| NIH Device Record Key | 3b9a2ff9-1558-4877-ab19-df3cf85547f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accessories |
| Version Model Number | 15-RF12-T |
| Catalog Number | 15-RF12-T |
| Company DUNS | 625272232 |
| Company Name | ORIGEN BIOMEDICAL, INC. |
| Device Count | 1 |
| 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 | 10816203023879 [Primary] |
| GS1 | 20816203023876 [Package] Contains: 10816203023879 Package: Carton [25 Units] In Commercial Distribution |
FDA Product Code
| KJG | Tube, Tissue Culture |
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 [Accessories]
| 20816203023432 | Two male luers to one spike port and one female luer with 20cm SCD tubing with pinch clamps. |
| 20816203023449 | 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing |
| 20816203022824 | One 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched |
| 20816203024330 | One female luer to eight spikes with 100cm of SCD tubing and pinch clamps |
| 10816203024197 | One 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched |
| 10816203024180 | Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps |
| 20816203024149 | One spike to one 3/8” barb with 12cm DMSO resistant tubing |
| 20816203023999 | One spike to one male luer with 50cm SCD tubing and pinch clamp |
| 20816203023982 | One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps |
| 20816203023975 | One spike to one female luer with 50cm of SCD tubing and pinch clamp |
| 20816203023968 | One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp |
| 20816203023944 | 3ml syringe on a female luer with 15cm sealed SCD tubing |
| 20816203023883 | 20ml syringe on a female luer with 15cm sealed SCD tubing |
| 20816203023876 | 12ml syringe on a female luer with 15cm sealed SCD tubing |
| 20816203023869 | 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing |
| 20816203023852 | 3ml syringe on a female luer with 15cm of SCD tubing |
| 20816203023845 | Needle-free vial spike, DMSO-resistant |
| 10816203023800 | DMSO-Resistant Bag Spike with needle injection port |
Trademark Results [Accessories]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCESSORIES 97145991 not registered Live/Pending |
taha s qattum 2021-11-29 |
 ACCESSORIES 79090741 not registered Dead/Abandoned |
S.Oliver Bernd Freier GmbH & Co. KG 2010-11-24 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.