FDA.reportPublic FDA data

Changke Connect

Primary DI
06973874210094
Brand
Changke Connect
Company
Shenzhen Changke Connect Electronics Co., Ltd.
Model
GCF1205
Published
2022-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
K191253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191253000Reusable NIBP CuffShenzhen Changke Connect Electronics Co., Ltd.2019-09-17DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973874210094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973874210094069738742100946973874210094

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.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
529906512
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973874210100Changke ConnectP01-001-005622022-03-04
06973874210117Changke ConnectP01-001-005632022-03-04
06973874210124Changke ConnectP01-001-005642022-03-04
06973874210131Changke ConnectP01-001-005652022-03-04
06973874210261Changke ConnectP01-001-005782022-03-04
16973874210107Changke ConnectP01-001-005702022-03-04
16973874210114Changke ConnectP01-001-005712022-03-04
16973874210121Changke ConnectP01-001-005722022-03-04
16973874210138Changke ConnectP01-001-005732022-03-04
06973874210018Changke ConnectCK-SMD-481A1-12AR22020-11-02
06973874210025Changke ConnectCK-SMD-582A1-03AR22020-11-02
06973874210032Changke ConnectCK-SMD-A82A1-03AN22020-11-02
06973874210049Changke ConnectCK-SMD-582A1-05AR22020-11-02
06973874210056Changke ConnectCK-SMD-982A1-05AR22020-11-02
06973874210148Changke ConnectP01-001-005662022-05-12
06973874210155Changke ConnectP01-001-005672022-05-12
06973874210162Changke ConnectP01-001-005682022-05-12
06973874210179Changke ConnectP01-001-005692022-05-12
16973874210145Changke ConnectP01-001-005742022-05-12
16973874210152Changke ConnectP01-001-005752022-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931973438504CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438511CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438528CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973454689CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456737CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456744CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456751CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456768CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456775CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456782CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456799CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456805CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456812CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456829CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456836CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456843CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456850CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456867CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456874CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456881CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456898CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456904CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456911CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456928CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456935CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456942CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456959CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456966CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456973CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456980CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09