| Primary Device ID | 00850836007410 |
| NIH Device Record Key | b757f568-b50b-42f4-a4b0-85aaf09ae4e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CautionWear PPE |
| Version Model Number | CW0001PPE |
| Company DUNS | 177056145 |
| Company Name | CAUTION WEAR CORP |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com | |
| Phone | 603-598-8500 |
| anatoli@cautionwearcorp.com |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850836007397 [Primary] |
| GS1 | 00850836007403 [Package] Contains: 00850836007397 Package: Inner Pack [1000 Units] In Commercial Distribution |
| GS1 | 00850836007410 [Package] Contains: 00850836007403 Package: Case [4 Units] In Commercial Distribution |
| GS1 | 00850836007427 [Package] Contains: 00850836007397 Package: Case [4000 Units] In Commercial Distribution |
| GS1 | 00850836007809 [Package] Contains: 00850836007397 Package: Plastic Bag [24 Units] In Commercial Distribution |
| GS1 | 00850836007816 [Package] Contains: 00850836007397 Package: Plastic Bag [50 Units] In Commercial Distribution |
| GS1 | 00850836007823 [Package] Contains: 00850836007397 Package: Plastic Bag [100 Units] In Commercial Distribution |
| GS1 | 00850836007830 [Package] Contains: 00850836007397 Package: Plastic Bag [200 Units] In Commercial Distribution |
| HIS | Condom |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-20 |
| 00850836007762 - CautionWear L.A.Confidential - Dark Desire | 2021-06-29 Male Latex Condom, Contoured, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir |
| 00850836007724 - CautionWear L.A.Confidential - Silky Touch | 2021-06-29 Male Latex Condom, Extra Lubricated, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Res |
| 00850836007069 - CautionWear L.A.Confidential - Secret Passion | 2021-06-28 Male Latex Condom, Studded, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir Ti |
| 00850836007212 - CautionWear Iron Grip | 2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Snugger Fit (49 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal |
| 00850836007250 - CautionWear Classic | 2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, |
| 00850836007328 - CautionWear Wild Rose | 2018-07-06 Male Latex Condom, Parallel-Sided, Ribbed Texture, Regular Fit (53 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal |
| 00850836007342 - FPA | 2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53 mm), Lubricated With Silicon Based Lubricant, Non-Spermicidal |
| 00850836007373 - CautionWear Black Ice | 2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Ultra Thin, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non- |