← Back to catalogue
Athena GTX Device Management Suite (ADMS) Software
FDA UDIClass II (US FDA UDI)
by Athena Gtx
Identity
- Trade Name
- Athena GTX Device Management Suite (ADMS) Software FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Athena GTX Device Management Suite - PC FDA UDI
- Model / Reference
- ADMS PC Software FDA UDI
- Description
- Athena GTX Device Management Suite - PC FDA UDI
Identifiers
- Catalog Number
- 390-0008-00 FDA UDI
- Primary DI / UDI-DI
- B3943900008000 FDA UDI
- 510(k) Number
- K173203 FDA UDI
- FDA Product Code
- MLD FDA UDIDQA FDA UDIDXN FDA UDIDSI FDA UDIMWI FDA UDIMHX FDA UDIDRG FDA UDIMSX FDA UDI
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI870.2700 FDA UDI870.1130 FDA UDI870.2300 FDA UDI870.2910 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Centralized patient monitor
Athena GTX Device Management Suite (ADMS) Software by Athena Gtx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Centralized patient monitor.
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
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
- Athena Gtx
Sources (1)
- FDA UDI a642a097-6ffc-4352-afbd-45d133acf276 36 fields · synced Jun 8, 2026