Primary Device ID | 00041163458291 |
NIH Device Record Key | 41792ef1-8ea6-4fcf-acec-af6dea663992 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Equaline Digital Pregnancy Test |
Version Model Number | CB8 PL |
Company DUNS | 483609579 |
Company Name | SPD SWISS PRECISION DIAGNOSTICS GMBH |
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 | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
xx@xx.xx | |
Phone | 800-899-7353 |
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 |
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 | 00041163458291 [Primary] |
GS1 | 00633472000041 [Unit of Use] |
GS1 | 10041163458298 [Package] Package: Shipping Case [24 Units] Discontinued: 2021-10-20 Not 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 | 4 |
Public Version Date | 2021-10-22 |
Device Publish Date | 2016-08-10 |
00633472602399 - Clearblue | 2024-08-12 Clearblue Ovul Dig 30ct. US |
00633472602405 - Clearblue | 2024-08-12 A convenience kit consisting of 30 Advanced Digital Ovulation tests + 2 Rapid Detection pregnancy tests |
00633472602412 - Clearblue | 2024-08-12 A convenience kit consisting of 15 Advanced Digital Ovulation tests + 1 Rapid Detection pregnancy tests |
10761706168537 - CVP Health | 2024-04-12 McLane (CVP Health) DPS +/- |
10633472602303 - Clearblue | 2024-02-14 Clearblue Preg Dig CB15 1ct - US |
10633472602310 - Clearblue | 2024-02-14 Clearblue Preg Dig CB15 5ct - US |
10633472602327 - Clearblue | 2024-02-14 A convenience kit consisting of 2 Digital Pregnancy Tests + 8 Visual Pregnancy Tests |
10633472602334 - Clearblue | 2024-02-14 A convenience kit consisting of 2 Digital pregnancy tests + 2 visual pregnancy tests |