Identity
- Trade Name
- SunWrap Upper Arm Right Small FDA UDI
- Generic Name
- Compression/pressure tubular garment FDA UDI
- Device Name
- SunWrap™ Compression System provides localized compression and visualization through a central transparent bladder covering the dressed site. SunWrap™ Compression systems provides localized compression and visualization to manage access site bleeding post-hemodialysis or any covered wound that would require compression to control bleeding. FDA UDI
- Model / Reference
- DA2150-00 FDA UDI
- Description
- SunWrap™ Compression System provides localized compression and visualization through a central transparent bladder covering the dressed site. SunWrap™ Compression systems provides localized compression and visualization to manage access site bleeding post-hemodialysis or any covered wound that would require compression to control bleeding. FDA UDI
Identifiers
- Catalog Number
- SW-BRS FDA UDI
- Primary DI / UDI-DI
- 00856525007051 FDA UDI
- 510(k) Number
- K070457 FDA UDI
- FDA Product Code
- MHW FDA UDI
- GMDN Term
- Compression/pressure tubular garment FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Compression/pressure tubular garment
SunWrap Upper Arm Right Small by Sun-Scientific Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070457 also covers:
- Aero-Wrap™ Bilateral Kit, Extra Large — SUN-SCIENTIFIC INC.
- Aero-Wrap™ Bilateral Kit, Large — SUN-SCIENTIFIC INC.
- Aero-Wrap™ Bilateral Kit, Medium — SUN-SCIENTIFIC INC.
- Aero-Wrap™ Bilateral Kit, Small — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
- AeroWrap™ — SUN-SCIENTIFIC INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sun-Scientific Inc.
Sources (1)
- FDA UDI 0f91bcfb-ad5a-4ded-8990-4e96b9ca925e 37 fields · synced May 30, 2026