One-Cuf One-A2-2A
by GE Medical Systems Information Technologies, Inc.
One-Cuf One-A2-2A is a Class II device made by GE Medical Systems Information Technologies, Inc., cleared under FDA 510(k) K230145 on 14 Mar 2023 and listed in FDA GUDID since 16 May 2023 (UDI-DI 00195278571397), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00195278571397 | Date16 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230145 | Date14 Mar 2023 | StatusActive |
Official records
- AccessGUDID record 00195278571397
- FDA 510(k) database K230145
Across registries
- FDA 510(k) K230145 decided 14 Mar 2023 Active
- FDA GUDID UDI-DI 00195278571397 listed 16 May 2023 Listed
Recalls
-
- Ongoing Z-2027-2024
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Timeline
- Cleared FDA 510(k) K230145
- Listed FDA GUDID 00195278571397
- Recall initiated FDA recalls Z-2027-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- One-Cuf
- Generic name
- Blood pressure cuff, single-use
- Model / reference
- ONE-A2-2A
- Description
- ONE-CUF, ADULT, DINACLICK 5 , 23 - 33 CM, SINGLE
- Primary DI / UDI-DI
- 00195278571397
- 510(k) Number
- FDA product code
- DXQ
- GMDN term
- Blood pressure cuff, single-use
- Device class
- Class II
- Regulation number
- 870.1120
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code DXQ (Blood Pressure Cuff).
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- MDF® MDF848AR12 by MDF Instruments Medifriend Inc.
- Bpump Blood Pressure Cuff by Shenzhen Pump Medical System Co., Ltd.
- MDF® MDF808M04 by MDF Instruments Medifriend Inc.
- GSIBP BLOOD PRESSURE CUFF by Globalshop, Inc.
- CUFF GUARD by Bowen Medical Services, Inc.
- UNICUF, BLOOD PRESSURE CUFF by Frontier Products
- SURGI-CUF REUSABLE, RS SERIES by Ethox International
- ALP-KII by Martin'S Maine Exchange
- Disposable NIBP Cuff by SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
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