ONE-CUF
ONE-CUF is a blood-pressure cuff used with a noninvasive blood-pressure monitor. An inflatable, nondistensible bladder wraps around the patient's limb and is inflated to temporarily occlude…
ONE-CUF is a blood-pressure cuff used with a noninvasive blood-pressure monitor. An inflatable, nondistensible bladder wraps around the patient’s limb and is inflated to temporarily occlude an artery during the measurement cycle.
One or two tubing connections allow air to enter and leave the bladder. The tubing terminates in connectors for attachment to the monitor’s blood-pressure hose.
Listed Item
ONE-CUF, Small Adult, 1 TB Bayonet, 17 – 25 CM, Single
Sizes and Connections
The range provides pediatric and adult sizes and bayonet or DINACLICK connection systems. Cuffs are supplied nonsterile for use on a single patient. They are not intended to be reprocessed for use on another patient and do not contain serviceable parts.
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) | K230145 |
| Record published | 2023-05-16 |
| Record revised | 2026-01-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 20 |
| Distribution end date | 2024-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ONE-P1-2A | Withdrawn | |
| ONE-A2-2A-L | Withdrawn | |
| ONE-A2-1B-L | Withdrawn | |
| ONE-P1-1B | Withdrawn | |
| ONE-A3-2A | Withdrawn | |
| ONE-A2-1B | Withdrawn | |
| ONE-A2-2A | Withdrawn | |
| ONE-P2-1B | Withdrawn | |
| ONE-A3-1B | Withdrawn | |
| ONE-A1-2A | Withdrawn | |
| ONE-A1-1B | Withdrawn | |
| ONE-P2-2A | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Medical Systems Information Technologies, Inc. | 510(k) number | 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.