| Primary Device ID | 40814434020774 |
| NIH Device Record Key | 16c1b023-7675-4fca-a5e7-7526a870a5c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Getinge Assured Smart-Read Biological Indicator, Getinge Assured AccuFast |
| Version Model Number | 504054100, 61301606636, 61301606637 |
| Catalog Number | 504054100, 61301606636, 61301606637 |
| Company DUNS | 622223196 |
| Company Name | STERITEC PRODUCT MFG. CO., 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814434020776 [Primary] |
| GS1 | 10814434020773 [Package] Contains: 00814434020776 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 20814434020770 [Package] Contains: 10814434020773 Package: Case [4 Units] In Commercial Distribution |
| GS1 | 30814434020777 [Package] Contains: 00814434020776 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 40814434020774 [Package] Contains: 00814434020776 Package: Box [100 Units] In Commercial Distribution |
| FRC | Indicator, Biological Sterilization Process |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |