| Primary Device ID | 10705037069583 |
| NIH Device Record Key | e8cf56f1-e498-4de7-ab2a-98e6b238eb1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ULTRA GI Cycle Validation Kit |
| Version Model Number | 43380 |
| Company DUNS | 947451626 |
| Company Name | ADVANCED STERILIZATION PRODUCTS SERVICES INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705037069583 [Primary] |
| FRG | Wrap, sterilization |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-03 |
| Device Publish Date | 2024-09-25 |
| 10705037067190 - Aptimax Instrument TRAY for ULTRA GI Cycle | 2024-10-03 Instrument Tray, Reusable |
| 10705037068425 - STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle | 2024-10-03 Plasma Sterilizer |
| 10705037068432 - STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle | 2024-10-03 Plasma Sterilizer |
| 10705037069583 - ULTRA GI Cycle Validation Kit | 2024-10-03STERRAD 100NX System ULTRA GI Cycle Validation Kit |
| 10705037069583 - ULTRA GI Cycle Validation Kit | 2024-10-03 STERRAD 100NX System ULTRA GI Cycle Validation Kit |
| 20705037069368 - ULTRA GI Process Challenge Device (PCD) Vial | 2024-10-03 ULTRA GI Cycle Process Challenge Device Vial |
| 10705037069316 - Evotech | 2024-06-28 Channel Connector Tube, Orange |
| 10705037068685 - Evotech | 2024-02-23 Channel Separator, PNTX |
| 10705037069309 - Evotech | 2024-02-23 Channel Connector Tube, Brown |