Identity
- Trade Name
- GRX Medical FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Model / Reference
- BP-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970366970085 FDA UDI
- 510(k) Number
- K082542 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
GRX Medical by Cardicare Company Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K082542 also covers:
- ASA Techmed — CARDICARE COMPANY LTD
- Leader — Cardinal Health 110, Inc.
- HealthSmart — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
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 |
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Manufacturer
- Manufacturer
- Cardicare Company Ltd
Sources (1)
- FDA UDI 8525ffb8-c5e8-45bb-b201-9156b303add0 35 fields · synced Jun 8, 2026