ziqing

Primary DI
06974560230648
Brand
ziqing
Company
Shenzhen Ziqing Medical Equipment Co.,Ltd.
Model
XB-01
Catalog number
XB-01
Device description
Upper arm electronic blood pressure monitor intended to measure systolic blood pressure, diastolic blood pressure, and pulse rate in adults (18 years and above). The device utilizes the oscillometric measurement method, automatically inflating the cuff to detect brachial artery blood flow and converting it into digital readings. Designed for simple and convenient operation, it is suitable for non-invasive auxiliary monitoring in home and clinical environments. Key features include an LCD display, a 2x99 user memory storage with average calculation, WHO blood pressure classification indication, optional voice broadcast, and an internal rechargeable lithium battery (DC 3.7V, 750mAh).
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253124000Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd.2026-06-03DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974560230648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974560230648069745602306486974560230648

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Regulatory Flags#

DUNS number
713519612
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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Primary DI, Brand, Company table
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