Identity
- Trade Name
- Elevate ArmBoard - Flat FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- The refurbished Flat ArmBoard Model 8100-F-U slides under a patient mattress and integrates with the single-use mBrace Model 4250 wrist support device to support a patient's arm during a cannulation procedure such as a catheterization into the radial artery. FDA UDI
- Model / Reference
- 8100-F-U FDA UDI
- Description
- The refurbished Flat ArmBoard Model 8100-F-U slides under a patient mattress and integrates with the single-use mBrace Model 4250 wrist support device to support a patient's arm during a cannulation procedure such as a catheterization into the radial artery. FDA UDI
Identifiers
- Catalog Number
- 180-0100-00-F-U FDA UDI
- Primary DI / UDI-DI
- 10815614020903 FDA UDI
- FDA Product Code
- FMQ FDA UDI
- GMDN Term
- Radiological arm/leg positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6760 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological arm/leg positioner
Elevate ArmBoard - Flat by Semler Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiological arm/leg positioner.
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- Arm Support — Medtec LLC · Class II
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- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
- Handle — Medtec LLC · Class II
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
- Semler Technologies, Inc.
Sources (1)
- FDA UDI 9a14a9e3-58be-4110-a42c-15291e987f1f 34 fields · synced Jun 8, 2026