FDA.reportPublic FDA data

Minhua

Primary DI
06971996170364
Brand
Minhua
Company
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
Model
MH002RCT07SL1
Device description
Reusable blood pressure cuff, Infant long, MH002RCT07SL1, 1PC/Pouch, 5PCS/Pouch, 100PCS/CTN. Package DI: 16971996170361, 26971996170368.
Published
2026-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171889000Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd.2017-12-19DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971996170361PackageGS15In Commercial Distribution
26971996170368PackageGS120In Commercial Distribution
06971996170364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697199617036116971996170361
2697199617036826971996170368
06971996170364069719961703646971996170364

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Regulatory Flags#

DUNS number
544313942
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971996170005MinhuaMH002RCP10-12026-08-07
06971996170012MinhuaMH002RCP10-22026-08-07
06971996170029MinhuaMH002RCP11-12026-08-07
06971996170036MinhuaMH002RCP11-22026-08-07
06971996170043MinhuaMH002RCP12-12026-08-07
06971996170050MinhuaMH002RCP12-22026-08-07
06971996170067MinhuaMH002RCP14-12026-08-07
06971996170074MinhuaMH002RCP14-22026-08-07
06971996170081MinhuaMH002RCP15-12026-08-07
06971996170098MinhuaMH002RCP15-22026-08-07
06971996170104MinhuaMH002RCP17-12026-08-07
06971996170111MinhuaMH002RCP17-22026-08-07
06971996170128MinhuaMH002RCT06HP12026-08-07
06971996170135MinhuaMH002RCT06HP22026-08-07
06971996170142MinhuaMH002RCT07HP12026-08-07
06971996170159MinhuaMH002RCT07HP22026-08-07
06971996170166MinhuaMH002RCT08HP12026-08-07
06971996170173MinhuaMH002RCT08HP22026-08-07
06971996170180MinhuaMH002RCT09HP12026-08-07
06971996170197MinhuaMH002RCT09HP22026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102524Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-10-16
00634782102449Multikuf™AMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782101725Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-03-30
06940211627693MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627709MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627969MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628010MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628027MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628034MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628041MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628058MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628065MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628089MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628096MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628102MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628126MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628133MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628140MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628157MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628164MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628188MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628263MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628317MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628515MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628522MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628539MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628546MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628584MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628669MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628676MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31