AeroWrap™ Flex Extra Large Bilateral MSB-XLF
GUDID 00856525007198
The AeroWrap ™ Flex System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ Flex gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap™ Flex Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg from the ankle to the knee. 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 | 00856525007198 |
| NIH Device Record Key | 48b43e2e-153f-4565-a4b0-a96f9686f78b |
| Commercial Distribution Discontinuation | 2030-10-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AeroWrap™ Flex Extra Large Bilateral |
| Version Model Number | Extra Large Flex Bi |
| Catalog Number | MSB-XLF |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856525007198 [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 | 2022-04-25 |
| Device Publish Date | 2022-04-15 |
Devices Manufactured by SUN SCIENTIFIC, INC.
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| 00850051939534 - CopperUnder sock Large | 2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester Large |
| 00850051939541 - CopperUnder sock Extra Large | 2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester Extra Large |
| 00850051939367 - ExuCare Scalp Large | 2024-08-26 ExuCare Scalp is a wrap dressing designed to provide drainage absorption for the Head |
| 00850051939374 - ExuCare Scalp Pediatric | 2024-08-26 ExuCare Scalp is a wrap dressing designed to provide drainage absorption for the Head |
| 00850051939381 - ExuCare Large with foot | 2024-08-08 A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury t |
| 00850051939398 - Exorb Ankle Large | 2024-08-08 A wound cover that wraps around the ankle which is intended to be used as an initial, short-term treatment after injury that con |
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 |
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