Aero-Wrap® Arm AWUE-SR
GUDID 00850051939312
The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy. The Aero-Wrap® Arm gradient compression sleeve is a non-sterile single patient use medical device. The Aero-Wrap® Arm, Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s full arm covering the bicep and forearm. An inflation source can be 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 clinical and outpatient use.
SUN SCIENTIFIC, INC.
Sequential venous compression system| Primary Device ID | 00850051939312 |
| NIH Device Record Key | b311ce80-1ae2-4335-ae1f-2a68d2af0cd0 |
| Commercial Distribution Discontinuation | 2030-10-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aero-Wrap® Arm |
| Version Model Number | AWUE-SR, Small Right |
| Catalog Number | AWUE-SR |
| Company DUNS | 609397224 |
| Company Name | SUN SCIENTIFIC, INC. |
| 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 | true |
| 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 | 00850051939312 [Primary] |
FDA Product Code
| 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 | 2024-02-26 |
| Device Publish Date | 2024-02-16 |
On-Brand Devices [Aero-Wrap® Arm]
| 00850051939350 | The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to prov |
| 00850051939343 | The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to prov |
| 00850051939336 | The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to prov |
| 00850051939329 | The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to prov |
| 00850051939312 | The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to prov |
| 00850051939305 | The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to prov |
Trademark Results [Aero-Wrap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AERO-WRAP 97081436 not registered Live/Pending |
Sun Scientific, Inc. 2021-10-19 |
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