RENASYS 66803112
GUDID 05000223499341
RENASYS Gauze Medium Wound Dressing Kit with AIRLOCK Technology and Soft Port
SMITH & NEPHEW MEDICAL LIMITED
Wound dressing kit, medicated| Primary Device ID | 05000223499341 |
| NIH Device Record Key | 35ead54e-bbc4-40cc-803d-1fd984b1429a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RENASYS |
| Version Model Number | 66803112 |
| Catalog Number | 66803112 |
| Company DUNS | 216344051 |
| Company Name | SMITH & NEPHEW MEDICAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight: - |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry: - |
| Special Storage Condition, Specify | Between 0 and 0 *Lower limit of temperature: - |
| Special Storage Condition, Specify | Between 0 and 0 *Upper limit of temperature: - |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05000223499150 [Primary] |
| GS1 | 05000223499341 [Package] Contains: 05000223499150 Package: CAS [5 Units] In Commercial Distribution |
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 | 2025-07-10 |
| Device Publish Date | 2025-07-02 |
On-Brand Devices [RENASYS]
| 00040565123943 | Power Cord North America |
| 30040565127232 | The RENASYS Procedure Packs are intended to be used in conjunction with Smith & Nephew NPWT syst |
| 00040565127309 | Renasys Canister Ring Holder US |
| 00040565126883 | RENASYS GO/TOUCH Class II Power Cord |
| 00040565126470 | Renasys EZ Max Hospital |
| 05000223491499 | Renasys EZ Max Quick Reference Guide US |
| 30040565127249 | Renasys Soft Port Stand Alone |
| 30040565125627 | Renasys Transparent Film Kit (Just Drapes) |
| 05000223499785 | RENASYS-WF White Foam NPWT Dressing Large |
| 05000223499761 | RENASYS-WF White Foam NPWT Dressing Small |
| 30040565125689 | Renasys EZ Plus Canister 250ml |
| 05000223500207 | Renasys-F XL Foam Dressing Kit With Soft Port |
| 05000223500184 | Renasys XL Transparent Film Dressing |
| 05000223499365 | RENASYS Gauze Small Wound Dressing Kit with AIRLOCK Technology and Soft Port |
| 05000223499341 | RENASYS Gauze Medium Wound Dressing Kit with AIRLOCK Technology and Soft Port |
| 05000223499327 | RENASYS Gauze Large Wound Dressing Kit with AIRLOCK Technology and Soft Port |
Trademark Results [RENASYS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RENASYS 79356442 not registered Live/Pending |
RENASYS AS 2022-10-05 |
 RENASYS 79356441 not registered Live/Pending |
RENASYS AS 2022-10-05 |
 RENASYS 78501495 not registered Dead/Abandoned |
Smith & Nephew, Inc. 2004-10-18 |
 RENASYS 77359907 3667380 Live/Registered |
T. J. Smith & Nephew, Limited 2007-12-27 |
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