AVELLE 421533
GUDID 00768455148882
Avelle™ Negative Pressure Wound Therapy Dressing 16X21Cm
CONVATEC, PURCHASING DEPARTMENT
Negative-pressure wound therapy system dressing set| Primary Device ID | 00768455148882 |
| NIH Device Record Key | 3eab7d54-e488-4a1c-ac05-694e44adf367 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVELLE |
| Version Model Number | 421533 |
| Catalog Number | 421533 |
| Company DUNS | 809784593 |
| Company Name | CONVATEC, PURCHASING DEPARTMENT |
| 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 | 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 |
Customer Support Contacts
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com |
Device Dimensions
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
| Width | 16 Centimeter |
| Length | 21 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00768455139262 [Primary] |
| GS1 | 00768455148882 [Package] Contains: 00768455139262 Package: Inner Carton [5 Units] In Commercial Distribution |
| GS1 | 10768455148889 [Package] Package: Shipper [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180205
FDA Product Code
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-19 |
| Device Publish Date | 2022-09-09 |
On-Brand Devices [AVELLE]
| 00768455155040 | Avelle™ Negative Pressure Wound Therapy Pump X6 Battery Pack |
| 00768455154357 | Avelle™ Negative Pressure Wound Therapy Dressing 26X26Cm |
| 00768455154340 | Avelle™ Negative Pressure Wound Therapy Dressing 21X26Cm |
| 00768455154333 | Avelle™ Negative Pressure Wound Therapy Dressing 12X41Cm |
| 00768455148905 | Avelle™ Negative Pressure Wound Therapy Dressing 12X31Cm |
| 00768455148899 | Avelle™ Negative Pressure Wound Therapy Dressing 12X21Cm |
| 00768455148882 | Avelle™ Negative Pressure Wound Therapy Dressing 16X21Cm |
| 00768455148875 | Avelle™ Negative Pressure Wound Therapy Dressing 16X16Cm |
| 00768455149070 | Avelle™ Negative Pressure Wound Therapy Carry Bag |
Trademark Results [AVELLE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVELLE 87952445 not registered Live/Pending |
ConvaTec Inc. 2018-06-07 |
 AVELLE 86397414 not registered Dead/Abandoned |
ConvaTec Inc. 2014-09-17 |
 AVELLE 85569665 not registered Dead/Abandoned |
ConvaTec Inc. 2012-03-14 |
 AVELLE 85569636 not registered Dead/Abandoned |
ConvaTec Inc. 2012-03-14 |
 AVELLE 77776888 not registered Dead/Abandoned |
ConvaTec Inc. 2009-07-08 |
 AVELLE 77703548 not registered Dead/Abandoned |
ConvaTec Inc. 2009-03-31 |
 AVELLE 77358869 not registered Dead/Abandoned |
Avelle, Inc. 2007-12-22 |
 AVELLE 77235699 not registered Dead/Abandoned |
ConvaTec Inc. 2007-07-23 |
 AVELLE 77143445 not registered Dead/Abandoned |
CONVATEC INC. 2007-03-29 |
 AVELLE 76310060 2658751 Live/Registered |
Xamax Industries, Inc. 2001-09-10 |
 AVELLE 75530641 not registered Dead/Abandoned |
Coca-Cola Company, The 1998-08-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.