| Primary Device ID | 00869839000496 | 
| NIH Device Record Key | 35e5416c-5bc7-4586-9c9a-b72269e1b0cf | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Casco Cup | 
| Version Model Number | Mid 2 | 
| Company DUNS | 604286695 | 
| Company Name | CASCO BAY MOLDING LTD. | 
| Device Count | 1000 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00869839000472 [Primary] | 
| GS1 | 00869839000496 [Unit of Use] | 
| HHE | Cup, Menstrual | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-10-21 | 
| Device Publish Date | 2020-10-13 | 
| 00869839000496 | Mid 47 Cone Menstrual Cup with 1 Engraved | 
| 00869839000489 | Mid 42 Cone Menstrual Cup with 1 Engraving | 
| 00869839000434 | Natural Mini 42 Cone Menstrual Cup with Mini Engraving | 
| 00869839000458 | Std 46 Cone Menstrual Cup with 2 Engraving | 
| 00869839000441 | Std 42 Cone Menstrual Cup with 1 Engraving | 
| 00850004683057 | Mid 47 Bell Menstrual Cup | 
| 00850004683040 | Mid 42 Bell Menstrual Cup | 
| 00850004683422 | 100% medical-grade silicone | 
| 00850004683415 | 100% medical-grade silicone | 
| 00850004683408 | 100% medical-grade silicone | 
| 00850004683668 | Casco Cup Mini w/Cloth Bag, Casco Cup Mid 1 w/2pc Case, Casco Cup Std 1 w/Cloth Bag | 
| 00850004683644 | Casco Cup Std 2 3pk, 2 w/Cloth Bag, 1 w/2pc Case | 
| 00850004683637 | Casco Cup Std 1 3pk, 2 w/Cloth Bag, 1 w/2pc Case | 
| 00850004683620 | 3 Mid 1 Cups 1 w/2pc Case, 2 w/Cloth Bag | 
| 00850004683613 | Casco Cup Mini 3pk with 2 cloth bags and 1 2pc case. | 
| 00850004683569 | Mini w/2pc Case | 
| 00850004683552 | Mid 1 w/2pc Case | 
| 00850004683545 | Std 2 w/2pc Case | 
| 00850004683538 | Std 1 w/2pc Case | 
| 00850004683507 | Mid 1 w/Cloth Bag | 
| 00850004683491 | Std 2 w/Cloth Bag | 
| 00850004683484 | Std 1 w/Cloth Bag | 
| 00850004683477 | Mini w/Cloth Bag | 
| 00850066493052 | Find Your Fit |