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Aura

FDA UDI

Class II (US FDA UDI)

by Branchpoint & Aura Development LLC

Identity

Trade Name
AURA FDA UDI
Generic Name
Medical networking interface unit FDA UDI
Device Name
AURA™ Data Receiver Pack FDA UDI
Model / Reference
DG101 FDA UDI
Description
AURA™ Data Receiver Pack FDA UDI

Identifiers

Primary DI / UDI-DI
G460DG1010 FDA UDI
510(k) Number
K172209 FDA UDI
FDA Product Code
GWM FDA UDI
GMDN Term
Medical networking interface unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1620 FDA UDI
Commercial Distribution
Not 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
MRI Safety
MR Unsafe FDA UDI

Aura by Branchpoint & Aura Development LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K172209 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Branchpoint & Aura Development LLC

Sources (1)

  • FDA UDI 3ff80e01-24fd-46ef-aa90-e6e19abe651b 37 fields · synced Jun 8, 2026