Identity
- Trade Name
- Amico Diagnostic Aneroid FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Aneroid Angled Gauge & Basket w Horiz Mnt Adlt 2-Piece Latex-Free Cuff 8ft Coil Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769) FDA UDI
- Model / Reference
- AM-AA-LF2118 FDA UDI
- Description
- Aneroid Angled Gauge & Basket w Horiz Mnt Adlt 2-Piece Latex-Free Cuff 8ft Coil Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00697077000011 FDA UDI
- 510(k) Number
- K012444 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
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Aneroid manual sphygmomanometer
Amico Diagnostic Aneroid by Amico Diagnostic Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Aneroid manual sphygmomanometer.
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- 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
Cleared under the same submission
K012444 also covers:
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
- Amico Diagnostic Aneroid — Amico Diagnostic Incorporated
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
- Amico Diagnostic Incorporated
Sources (1)
- FDA UDI a38b3468-44ca-4011-ac3a-ee0017eca3ae 35 fields · synced May 31, 2026