| Primary Device ID | 05708932015097 |
| NIH Device Record Key | 5fb2a14c-1eb7-4b19-a74d-6fb77d8679ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfeel Plus Transparent |
| Version Model Number | 33539 |
| Catalog Number | 33539 |
| Company DUNS | 305524696 |
| Company Name | Coloplast A/S |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Width | 6 Inch |
| Length | 6 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932015073 [Primary] |
| GS1 | 05708932015080 [Package] Contains: 05708932015073 Package: Retail Box [5 Units] In Commercial Distribution |
| GS1 | 05708932015097 [Package] Contains: 05708932015080 Package: Shipper Box [14 Units] In Commercial Distribution |
| NAD | Dressing, wound, occlusive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-21 |
| Device Publish Date | 2022-03-11 |
| 05708932641623 | Comfeel Plus Transparent Hydrocolloid Dressing Dressing Length 14 cm, Dressing Length 5 in, |
| 05708932641609 | Comfeel Plus Transparent Hydrocolloid Dressing Dressing Length 10 cm, Dressing Length 4 in, Dr |
| 05708932641579 | Comfeel Plus Transparent Hydrocolloid Dressing Dressing Length 7 cm, Dressing Length 2.75 in |
| 05708932015097 | Comfeel Plus Transparent Hydrocolloid Dressing Dressing Length 15 cm, Dressing Length 6 in, Dr |