FDA.reportPublic FDA data

Disposable Cuff

Primary DI
10840935106937
Brand
Disposable Cuff
Company
SUNTECH MEDICAL, INC.
Model
98-0400-C5
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K080854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080854000DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100Suntech Medical, Inc.2008-10-20DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840935106937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084093510693710840935106937

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

Contacts#

Phone, Email table
PhoneEmail
+1-919-654-2300UDI_MAIL@suntechmed.com

Regulatory Flags#

DUNS number
148191133
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840935111702Straight Black Hose, Female Bayonet to Female Bayonet, 9.8ft (3m), Siemens91-0032-332025-12-01
10840935111719Straight Gray Hose, Female Luer to Female Bayonet, 9.8ft (3m), Siemens91-0032-342025-12-01
10840935111696Patient Hose91-0028-232025-11-18
10840935111580Adult Orbit-K Cuff with Microphone, Bayonet, Reverse Orientation98-0062-392025-09-10
10840935111597Adult Plus Orbit-K Cuff with Microphone, Bayonet, Reverse Orientation98-0062-402025-09-10
10840935111603Large Adult Orbit-K Cuff with Microphone, Bayonet, Reverse Orientation98-0062-412025-09-10
10840935110507Patient Hose, 1.2 meter Bayonet, Black, RDT91-0028-322025-07-29
10840935110514Patient Hose, 8 feet, with Female Bayonet Connect and Male Inline Right Angle Pu91-0028-802025-07-29
10840935110521Straight Black Hose, Female Bayonet to Male Inline Right Angle Connector, 10ft (91-0028-982025-07-29
10840935107552Disposable Cuff98-0699-042017-05-25
10840935107569Disposable cuff98-0699-052017-05-25
10840935107576Disposable cuff98-0399-C02017-05-25
10840935107583Disposable Cuff98-0399-C12017-05-25
10840935107606Disposable cuff98-0399-C32017-05-25
10840935107620Disposable cuff98-0399-C52017-05-25
10840935107637disposable cuff98-0399-C62017-05-25
10840935107644Disposable Cuff98-0399-C72017-05-25
10840935107651Disposable cuff98-0399-C82017-05-25
10840935107668Disposable cuff98-0399-C92017-05-25
10840935108085Disposable Cuff98-0399-3K2018-11-21

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