Primary Device ID | 10768455193049 |
NIH Device Record Key | b69fb810-7846-49f4-8862-25e74284d4b7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ESENTA |
Version Model Number | 423290 |
Company DUNS | 809784593 |
Company Name | CONVATEC, PURCHASING DEPARTMENT |
Device Count | 1 |
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 | true |
Phone | +18004228811 |
cic@convatec.com |
Total Volume | 150 Milliliter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00768455193042 [Primary] |
GS1 | 10768455193049 [Package] Contains: 00768455193042 Package: [1 Units] In Commercial Distribution |
EXE | PROTECTOR, OSTOMY |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-10 |
Device Publish Date | 2022-09-30 |
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 |