Identity
- Trade Name
- Velcro cuff small adult size 42x13cm, FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Riester cuffs are used to generate pressure when measuring blood pressure. FDA UDI
- Model / Reference
- 121.002 FDA UDI
- Description
- Riester cuffs are used to generate pressure when measuring blood pressure. FDA UDI
Identifiers
- Catalog Number
- 121.002 FDA UDI
- Primary DI / UDI-DI
- 04045396216860 FDA UDI
- 510(k) Number
- K972301 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Blood pressure cuff, reusable 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood pressure cuff, reusable
Velcro cuff small adult size 42x13cm, by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood pressure cuff, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Orbit-K — SUNTECH MEDICAL, INC. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- MDF® — MDF Instruments Medifriend Inc. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- Extra Large Cuff Assembly for HEM-907XL — Omron Healthcare, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K972301 also covers:
- Extension module big ben® square, — Rudolf Riester GmbH & Co. KG
- Extension module big-ben® square, adult size bandage cuff, ri-former® — Rudolf Riester GmbH & Co. KG
- Extension module big-ben® square, adult size hook cuff, ri-former® — Rudolf Riester GmbH & Co. KG
- Extension module big-ben® square, child size velcro cuff, ri-former® — Rudolf Riester GmbH & Co. KG
- Extension module big-ben® square, obese size velcro cuff, ri-former® — Rudolf Riester GmbH & Co. KG
- Velcro cuff 2 tubes, adults — Rudolf Riester GmbH & Co. KG
- Velcro cuff child size 35, 5 x 10 cm, — Rudolf Riester GmbH & Co. KG
- Velcro cuff infant size, 23 x 7.2 cm, — Rudolf Riester GmbH & Co. KG
- Velcro cuff obese size, 70 x 15 cm, — Rudolf Riester GmbH & Co. KG
- Velcro cuff thigh size 70 x 22cm, 2tubes, black — Rudolf Riester GmbH & Co. KG
- big ben® round anaesthetic manometer, without accessories, without clamp — Rudolf Riester GmbH & Co. KG
- big ben® round anaesthetic, adult size bandage 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 5f9b3bf3-3987-4f5d-9708-1cd3970fa7c1 35 fields · synced Jun 8, 2026