Identity
- Trade Name
- GAMMA G7 FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Model / Reference
- 000 FDA UDI
Identifiers
- Catalog Number
- M-000.09.247 FDA UDI
- Primary DI / UDI-DI
- 04053755136438 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Aneroid manual sphygmomanometer
Gamma G7 by Heine Optotechnik GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aneroid manual sphygmomanometer.
- Diagnostix™ — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- e-mega® black, disinfectable one-piece cuff, small adult size 2-tube — Rudolf Riester GmbH & Co. KG · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- Princess — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- E-sphyg™ — American Diagnostic Corporation · Class II
- BAUM — W.A. BAUM CO., INC. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heine Optotechnik GmbH & Co. KG
Sources (1)
- FDA UDI 9fa3cd45-f16d-4ba8-a5d8-aeebc148e300 34 fields · synced Jun 1, 2026