| Primary Device ID | 00072000793138 |
| NIH Device Record Key | 4deca5c6-5480-4729-8ca2-198342e1b059 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smart Sense Early Result Pregnancy Test |
| Version Model Number | PLPL |
| Company DUNS | 131978533 |
| Company Name | KMART HOLDING CORPORATION |
| Device Count | 2 |
| 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 | 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 |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx | |
| Phone | 800-842-7886 |
| xx@xx.xx |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00072000793138 [Primary] |
| GS1 | 00633472000126 [Unit of Use] |
| GS1 | 10072000793135 [Package] Package: Shipping Case [24 Units] In Commercial Distribution |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | 2016-07-04 |
| 10883967382238 - Smart Sense Tampons | 2019-12-09 |
| 10883967382245 - Smart Sense Tampons | 2019-12-09 |
| 10883967382252 - Smart Sense Tampons | 2019-12-09 |
| 10883967382269 - Smart Sense Tampons | 2019-12-09 |
| 10883967418340 - SMART SENSE Tampons | 2019-12-09 |
| 10883967418364 - SMART SENSE Tampons | 2019-12-09 |
| 10883967418371 - SMART SENSE Tampon | 2019-12-09 |
| 00883967296910 - Image Essentials One Step Pregnancy Test | 2018-07-06 FPPL Kmart Image Essentials SPS +/- |