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sphygmotensiophone, adult size velcro cuff pull through strap
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- sphygmotensiophone, adult size velcro cuff pull through strap FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure. FDA UDI
- Model / Reference
- 1380 FDA UDI
- Description
- Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure. FDA UDI
Identifiers
- Catalog Number
- 1380 FDA UDI
- Primary DI / UDI-DI
- 04045396001930 FDA UDI
- 510(k) Number
- K942649 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Aneroid manual sphygmomanometer
sphygmotensiophone, adult size velcro cuff pull through strap by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Aneroid manual sphygmomanometer.
- Diagnostix™ — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · 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
- Amico Diagnostic Station — Amico Diagnostic Incorporated · Class II
Cleared under the same submission
K942649 also covers:
- minimus® III manometer, without cuff — Rudolf Riester GmbH & Co. KG
- minimus® III, adult size bandage cuff — Rudolf Riester GmbH & Co. KG
- minimus® III, adult size hook cuff — Rudolf Riester GmbH & Co. KG
- minimus® III, adult size velcro cuff — Rudolf Riester GmbH & Co. KG
- minimus® III, child size velcro cuff — Rudolf Riester GmbH & Co. KG
- minimus® III, obese size velcro cuff (2 tubes) — Rudolf Riester GmbH & Co. KG
- minimus® III, velcro cuff, — Rudolf Riester GmbH & Co. KG
- sanaphon® manometer, without cuff, without stethoscope — Rudolf Riester GmbH & Co. KG
- sanaphon® with stethoscope, adult size velcro cuff pull through strap — Rudolf Riester GmbH & Co. KG
- sanaphon® with stethoscope, child size velcro cuff pull through strap — Rudolf Riester GmbH & Co. KG
- sanaphon® with stethoscope, obese size velcro cuff pull through strap — Rudolf Riester GmbH & Co. KG
- sphygmotensiophone manometer, without cuff — Rudolf Riester GmbH & Co. KG
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
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI cfff6880-2fcb-42c3-985f-020b4c37577c 35 fields · synced Jun 6, 2026