AeroWrap™ AW-LMB
GUDID 00856525007266
The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg. An inflation source is attached to the inflation valve on the sleeve. There is a inflation source provided: a hand pump to provide static compression. The system is intended for hospital and outpatient use.
SUN SCIENTIFIC, INC.
Sequential venous compression system| Primary Device ID | 00856525007266 |
| NIH Device Record Key | fd0627b0-99e3-4718-927c-a87f49e01acf |
| Commercial Distribution Discontinuation | 2030-10-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AeroWrap™ |
| Version Model Number | Medium |
| Catalog Number | AW-LMB |
| Company DUNS | 609397224 |
| Company Name | SUN SCIENTIFIC, INC. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856525007266 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070457
FDA Product Code
| JOW | Sleeve, Limb, Compressible |
| MHW | Dressing, Compression |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-10 |
| Device Publish Date | 2021-04-30 |
On-Brand Devices [AeroWrap™ ]
| 00856525007303 | The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide |
| 00856525007280 | The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide |
| 00856525007266 | The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide |
| 00856525007242 | The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide |
| 00856525007228 | The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide |
| 00856525007204 | The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide |
| 00856525007181 | The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide |
| 00856525007167 | The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide |
Trademark Results [AeroWrap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AEROWRAP 74078708 1694903 Dead/Cancelled |
FPM, INC. 1990-07-16 |
 AEROWRAP 73750051 1704856 Dead/Cancelled |
BXL PLASTICS LIMITED 1988-09-06 |
 AEROWRAP 73674182 1479604 Live/Registered |
SALEM LABEL COMPANY, INC. 1987-07-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.