Classic-CUF
CLASSIC-CUF is a limb cuff for indirect blood-pressure measurement using a manual or automated system. Its nondistensible inflatable bladder encircles the limb and temporarily compresses…
CLASSIC-CUF is a limb cuff for indirect blood-pressure measurement using a manual or automated system. Its nondistensible inflatable bladder encircles the limb and temporarily compresses the artery as air enters and leaves.
The cuff connects to the blood-pressure equipment through tubing and a model-specific connector. The family provides limited-reuse or single-patient configurations rather than one uniform reuse arrangement.
Listed Item
Classic-CUF, Large Adult Long, 2 TB Mated Submin, 31 – 40 CM, Single
Patient and Connector Options
Adult and pediatric configurations include a fused dual-tube bayonet connection called CLICK-IT. Neonatal configurations use a separate SNAP-IT disconnect connection. Cuff size, tubing and connection must correspond to the patient group and compatible blood-pressure equipment.
Who Else Makes It
Concentrated in Guangdong (22), Zhejiang (13), Jiangsu (7). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| A&D Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Suntech Medical Devices (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shanghai Minhua Medical Apparatus Supplies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Wenzhou Naisi Health Product Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 50. All 50 manufacturers in China registered for Blood Pressure Cuff
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | DXQ |
| Device type | Blood Pressure Cuff |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1120 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K120125 |
| Record published | 2016-06-30 |
| Record revised | 2026-01-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature -20 to 55 °C |
| Packaging | Pack of 20 |
| Distribution end date | 2025-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2138 | NEONATAL1 | In distribution |
| 2623 | NEONATAL4 | In distribution |
| 2303 | Adult | In distribution |
| CLA-P2-2A | Child | In distribution |
| CLA-N3-1B | NEONATAL3 | In distribution |
| 2302 | Small Adult | In distribution |
| CLA-N3-2B | NEONATAL3 | In distribution |
| 2306 | Adult Long | In distribution |
| CLA-A1-2A | Small Adult | In distribution |
| CLA-N4-1B | NEONATAL4 | In distribution |
| 2301 | Child | In distribution |
| 2128 | NEONATAL3 | In distribution |
| 2619 | NEONATAL5 | In distribution |
| 2300 | Infant | In distribution |
| 2119 | NEONATAL5 | In distribution |
| 2633 | NEONATAL2 | In distribution |
| 2305 | Thigh | In distribution |
| CLA-N5-1B | NEONATAL5 | In distribution |
| CLA-N1-2B | NEONATAL1 | In distribution |
| 2304 | Large Adult | In distribution |
| CLA-N5-2B | NEONATAL5 | In distribution |
| CLA-A2-2A | Adult | In distribution |
| 2133 | NEONATAL2 | In distribution |
| 2123 | NEONATAL4 | In distribution |
| 2628 | NEONATAL3 | In distribution |
| 2307 | Large Adult Long | In distribution |
| CLA-N1-1B | NEONATAL1 | In distribution |
| CLA-A1-2A-L | Small Adult Long | In distribution |
| CLA-N2-2B | NEONATAL2 | In distribution |
| CLA-N4-2B | NEONATAL4 | In distribution |
| CLA-P1-2A | Infant | In distribution |
| CLA-N2-1B | NEONATAL2 | In distribution |
| 2356 | Small Adult | Withdrawn |
| 2357 | Adult | Withdrawn |
| 2175 | Large Adult | Withdrawn |
| 2358 | Large Adult | Withdrawn |
| 2670 | Infant | Withdrawn |
| 2359 | Thigh | Withdrawn |
| 2607 | Small Adult | Withdrawn |
| 2173 | Adult | Withdrawn |
| 2648 | Thigh | Withdrawn |
| 2675 | Thigh | Withdrawn |
| 2642 | Large Adult | Withdrawn |
| 2172 | Small Adult | Withdrawn |
| 2608 | Small Adult | Withdrawn |
| 2638 | NEONATAL1 | Withdrawn |
| CLA-A1-2A-X | Small Adult | Withdrawn |
| CLA-A3-2A-X | Large Adult | Withdrawn |
| 2672 | Small Adult | Withdrawn |
| 2673 | Adult | Withdrawn |
| CLA-A3-2A | Large Adult | Withdrawn |
| 2649 | Large Adult Long | Withdrawn |
| CLA-P1-2A-X | Infant | Withdrawn |
| 2353 | Large Adult Long | Withdrawn |
| 2177 | Thigh | Withdrawn |
| 2647 | Adult Long | Withdrawn |
| 2174 | Adult Long | Withdrawn |
| 2603 | Adult | Withdrawn |
| 2650 | Infant | Withdrawn |
| 2355 | Child | Withdrawn |
| 2643 | Large Adult | Withdrawn |
| 2652 | Thigh | Withdrawn |
| CLA-A2-2A-X | Adult | Withdrawn |
| CLA-A2-2A-X-5S | Adult | Withdrawn |
| CLA-P2-2A-X | Child | Withdrawn |
| 2651 | Child | Withdrawn |
| 2354 | Infant | Withdrawn |
| CLA-A3-2A-L | Large Adult Long | Withdrawn |
| 2171 | Child | Withdrawn |
| 2613 | Child | Withdrawn |
| 2602 | Adult | Withdrawn |
| CLA-T1-2A | Thigh | Withdrawn |
| 2176 | Large Adult Long | Withdrawn |
| 2170 | Infant | Withdrawn |
| CLA-T1-2A-X | Thigh | Withdrawn |
| 2352 | Adult Long | Withdrawn |
| 2618 | Infant | Withdrawn |
| CLA-A2-2A-L | Adult Long | Withdrawn |
| 2671 | Child | Withdrawn |
| 2674 | Large Adult | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 1,801 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,310 |
| Diagnostix™ | American Diagnostic Corp. | 681 |
| Orantech | Orantech Inc. | 648 |
| Blood Pressure Cuff | Salter Labs | 425 |
| Aneroids (82 etc.) | Rashman Corp. | 418 |
| Medline | Medline Industries, Inc. | 390 |
| Baum | W.A. Baum Co., Inc. | 349 |
| Adcuff™ | American Diagnostic Corp. | 348 |
| Disposable cuff | Suntech Medical, Inc. | 326 |
| Vistarmed | Shenzhen Vistar Medical Supplies Co., Ltd. | 254 |
| Statcorp Medical | Statcorp, Inc. | 229 |
Showing 12 of 598. All products under Blood Pressure Cuff
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230145 | 2023-03-14 |
| K123996 | 2013-04-09 |
| K120125 | 2012-10-03 |
| K022482 | 2002-08-13 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-04-09 | Class II | Under Investigation by firm | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. | 23,180/20-cuff boxes |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.