Primary Device ID | 20067981087769 |
NIH Device Record Key | 47a28f8e-8613-47ee-ba0b-b2f5c69948ea |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KY Intense Condoms |
Version Model Number | Condom |
Company DUNS | 081049410 |
Company Name | RB Health (us) LLC |
Device Count | 3 |
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 | 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 | +1(800)756-5488 |
xxx@xxx.xxx |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00067981087765 [Primary] |
GS1 | 10067981087762 [Package] Contains: 00067981087765 Package: Carton [6 Units] In Commercial Distribution |
GS1 | 20067981087769 [Package] Contains: 10067981087762 Package: Case [24 Units] In Commercial Distribution |
GS1 | 40067981087763 [Unit of Use] |
HIS | CONDOM |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-20 |
Device Publish Date | 2019-06-12 |
20679810872707 | Condom |
20679810872608 | Condom |
20679810872509 | Condom |
20067981087264 | Condom |
10067981087250 | Condom |
20067981087769 | Condom |
10067981087274 | Condom |