Identity
- Trade Name
- AURA FDA UDI
- Generic Name
- Ambulatory monitoring/recording system transceiver/cable FDA UDI
- Device Name
- AURA™ Antenna FDA UDI
- Model / Reference
- TA101 FDA UDI
- Description
- AURA™ Antenna FDA UDI
Identifiers
- Catalog Number
- TA101 FDA UDI
- Primary DI / UDI-DI
- 00860011785248 FDA UDI
- 510(k) Number
- K172209 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Ambulatory monitoring/recording system transceiver/cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Ambulatory monitoring/recording system transceiver/cable
Aura by Branchpoint & Aura Development LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ambulatory monitoring/recording system transceiver/cable.
- SENSIMED Triggerfish® Data Cable — Sensimed AG · Class II
- ActiGraph — ActiGraph L.L.C. · Class I
- Bedside Mobility Monitor — ATLAS LIFT TECH, INC. · Class I
- LEAF™ — Smith & Nephew Medical, Ltd. · Class I
- LEAF™ — Smith & Nephew Medical, Ltd. · Class I
- LEAF™ — Smith & Nephew Medical, Ltd. · Class I
Cleared under the same submission
K172209 also covers:
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
- AURA — Branchpoint & Aura Development LLC
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Branchpoint & Aura Development LLC
Sources (1)
- FDA UDI 6d22542c-5c8d-4c39-8004-1d5fedbdcdf9 37 fields · synced Jun 8, 2026