| Primary Device ID | 10768455107039 |
| NIH Device Record Key | 48f4c118-9010-4fd9-8af7-f6948d6f1a79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLEXI-SEAL FMS |
| Version Model Number | 650078 |
| Company DUNS | 809784593 |
| Company Name | CONVATEC, PURCHASING DEPARTMENT |
| Device Count | 10 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00768455107032 [Primary] |
| GS1 | 00768455150915 [Unit of Use] |
| GS1 | 10768455107039 [Package] Contains: 00768455107032 Package: Case [6 Units] In Commercial Distribution |
| GS1 | 80768455107038 [Unit of Use] |
| EZQ | Pouch, Colostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-07 |
| Device Publish Date | 2018-12-07 |
| 10768455107039 | Flexi-Seal Fecal Collector |
| 10768455107909 | Flexi-Seal FMS Collection Bags |