| Primary Device ID | 00810396020304 |
| NIH Device Record Key | d6f037ab-6445-47cf-b4e8-8c04859734ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Stork OTC |
| Version Model Number | 1000-030 |
| Company DUNS | 968804521 |
| Company Name | STORK IB2C, INC., THE |
| 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 412-200-7996 |
| info@rinovum.com | |
| Phone | 412-200-7996 |
| info@rinovum.com |
| Storage Environment Temperature | Between -30 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 54 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810396020304 [Primary] |
| OBB | Kit, Conception-Assist, Home Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-11 |
| 00810396020335 | The Stork, Merck Femibion |
| 00810396020311 | Stork OTC, Walgreens, S-Box |
| 00810396020304 | Stork OTC, General, S-Box |
| 00810396020199 | The Stork OTC, General |
| 00810396020090 | The Stork, UK |
| 00810396020083 | The Stork OTC, CVS |