| Primary Device ID | B415CSXB000 |
| NIH Device Record Key | d8e71226-2f43-4121-85bd-b8b5ebfeeb67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MeLuna |
| Version Model Number | Classic Clear Ball X-Large Standard |
| Catalog Number | C-SXB-00 |
| Company DUNS | 026952939 |
| Company Name | MeLuna USA |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B415CSXB000 [Primary] |
| HHE | Cup, Menstrual |
| 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 | 2016-11-17 |
| B415SSXS200 | Sport Sapphire Stem X-Large Standard |
| B415SSXS100 | Sport Amethyst Stem X-Large Standard |
| B415SSXS000 | Sport Clear Stem X-Large Standard |
| B415SSXR200 | Sport Sapphire Ring X-Large Standard |
| B415SSXR100 | Sport Amethyst Ring X-Large Standard |
| B415SSXR000 | Sport Clear Ring X-Large Standard |
| B415SSXB200 | Sport Sapphire Ball X-Large Standard |
| B415SSXB100 | Sport Amethyst Ball X-Large Standard |
| B415SSXB000 | Sport Clear Ball X-Large Standard |
| B415SSSS100 | Sport Amethyst Stem Small Standard |
| B415SSSS000 | Sport Clear Stem Small Standard |
| B415SSSR200 | Sport Sapphire Ring Small Standard |
| B415SSSR100 | Sport Amethyst Ring Small Standard |
| B415SSSR000 | Sport Clear Ring Small Standard |
| B415SSSB200 | Sport Sapphire Ball Small Standard |
| B415SSSB100 | Sport Amethyst Ball Small Standard |
| B415SSSB000 | Sport Clear Ball Small Standard |
| B415SSS200 | Sport Sapphire Stem Small Standard |
| B415SSMS200 | Sport Sapphire Stem Medium Standard |
| B415SSMS100 | Sport Amethyst Stem Medium Standard |
| B415SSMS000 | Sport Clear Stem Medium Standard |
| B415SSMR200 | Sport Sapphire Ring Medium Standard |
| B415SSMR100 | Sport Amethyst Ring Medium Standard |
| B415SSMR000 | Sport Clear Ring Medium Standard |
| B415SSMB200 | Sport Sapphire Ball Medium Standard |
| B415SSMB100 | Sport Amethyst Ball Medium Standard |
| B415SSMB000 | Sport Clear Ball Medium Standard |
| B415SSLS200 | Sport Sapphire Stem Large Standard |
| B415SSLS100 | Sport Amethyst Stem Large Standard |
| B415SSLS000 | Sport Clear Stem Large Standard |
| B415SSLR200 | Sport Sapphire Ring Large Standard |
| B415SSLR100 | Sport Amethyst Ring Large Standard |
| B415SSLR000 | Sport Clear Ring Large Standard |
| B415SSLB200 | Sport Sapphire Ball Large Standard |
| B415SSLB100 | Sport Amethyst Ball Large Standard |
| B415SSLB000 | Sport Clear Ball Large Standard |
| B415SPXS200 | Sport Sapphire Stem X-Large Shorty |
| B415SPXS100 | Sport Amethyst Stem X-Large Shorty |
| B415SPXS000 | Sport Clear Stem X-Large Shorty |
| B415SPXR200 | Sport Sapphire Ring X-Large Shorty |
| B415SPXR100 | Sport Amethyst Ring X-Large Shorty |
| B415SPXR000 | Sport Clear Ring X-Large Shorty |
| B415SPXB200 | Sport Sapphire Ball X-Large Shorty |
| B415SPXB100 | Sport Amethyst Ball X-Large Shorty |
| B415SPXB000 | Sport Clear Ball X-Large Shorty |
| B415SPSS200 | Sport Sapphire Stem Small Shorty |
| B415SPSS100 | Sport Amethyst Stem Small Shorty |
| B415SPSS000 | Sport Clear Stem Small Shorty |
| B415SPSR200 | Sport Sapphire Ring Small Shorty |
| B415SPSR100 | Sport Amethyst Ring Small Shorty |