| Primary Device ID | 10851950008045 |
| NIH Device Record Key | 5252634e-6561-4bda-90b8-b96d0856e887 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arvolife |
| Version Model Number | Fertility Kit |
| Company DUNS | 827033924 |
| Company Name | Clinical Guard |
| Device Count | 70 |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851950008048 [Primary] |
| GS1 | 00851950008109 [Unit of Use] |
| GS1 | 10851950008045 [Package] Contains: 00851950008048 Package: [60 Units] In Commercial Distribution |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-04-27 |
| Device Publish Date | 2018-03-27 |
| 00851950008154 | Drug Test Cup |
| 00851950008147 | Drug Test Panel |
| 10851950008137 | HCG Midstream |
| 00851950008123 | THC Marijuana Drug Test Strip |
| 10851950008045 | 50 Ovulation Tests and 20 Pregnancy Tests Comb Kit |