| Primary Device ID | 10768455209481 | 
| NIH Device Record Key | ed53ed26-47c7-4115-bf06-382bd2ecb913 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ESENTA | 
| Version Model Number | 423827 | 
| Company DUNS | 809784593 | 
| Company Name | CONVATEC, PURCHASING DEPARTMENT | 
| Device Count | 20 | 
| 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 | false | 
| OTC Over-The-Counter | false | 
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | |
| Phone | +18004228811 | 
| cic12@convatec.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00768455209484 [Primary] | 
| GS1 | 00768455209637 [Unit of Use] | 
| GS1 | 10768455209481 [Package] Contains: 00768455209484 Package: [44 Units] In Commercial Distribution | 
| EXE | Protector, ostomy | 
| FON | Bag, drainage, with adhesive, ostomy | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-09-03 | 
| Device Publish Date | 2024-08-26 | 
| 10768455170095 | Esenta™ Skin Barrier Foam Applicator 3 ml, Sterile (25 per pack) | 
| 10768455170064 | Esenta™ Skin Barrier Foam Applicator 1 ml, Sterile (5 per pack) | 
| 10768455193070 | Esenta™ Skin Barrier Wipe (25EA/PK; 20PK/CS) Non-sterile | 
| 10768455193063 | Esenta™ Adhesive Remover Wipe (25EA/PK; 20PK/CS) Non-sterile | 
| 10768455193049 | Esenta™ Adhesive Remover Spray (150 ml) Sterile | 
| 10768455170132 | Esenta™ Adhesive Remover Spray (50 ml) Non-sterile | 
| 10768455170125 | Esenta™ Skin Barrier Spray (50 ml) Non-sterile | 
| 10768455170088 | Esenta™ Skin Barrier Pump Spray (28 ml) Non-sterile | 
| 10768455209511 | ESENTA THIN CURVE 3X9CM (1X80PK) NAI | 
| 10768455209481 | ESENTA THIN XL SEMI CIRCLE (1X20PK) EUR | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ESENTA  79336676  not registered Live/Pending | ConvaTec Inc. 2021-12-15 | 
|  ESENTA  79292607  not registered Live/Pending | ConvaTec Inc. 2020-06-19 |