FDA.reportPublic FDA data

SoftCheck

Primary DI
00858293006595
Brand
SoftCheck
Company
REPROCESSING PRODUCTS CORPORATION
Model
ST2938FL
Device description
BP Cuff, Long Adult, 29-38 cm, 1 Tube
Published
2019-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K940214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940214000STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFFStatcorp, Inc.1994-02-22DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858293006592PackageGS15In Commercial Distribution
00858293006595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085829300659210858293006592
00858293006595008582930065958582930065950858293006595

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, single-useA 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 typically wrapped around the upper arm of the patient. This is a single-use device.

Regulatory Flags#

DUNS number
796083392
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858293006939Peracidin0818942026-07-24
00858293006946Peracidin0818962026-07-24
00858293006328EZ-ChekK100-0101BK100-0101B2017-03-07
00858293006915Accu-ReadBP00-22012025-04-02
00858293006120Micro-XK100-0105K100-01052017-03-07
00858293006922Micro-XMX-32122023-02-20
00858293006458Luer Fitting FemaleBF00-00102019-08-30
00858293006465Luer Fitting MaleBF00-00112019-08-30
00858293006496Black Tubing, NaturalBT00-01002019-08-30
00858293006502Black Tubing, PVCBT00-01032019-08-30
00858293006908Spiral Coil Tubing, Trans BluePU532-8TD0PU532-8WT02021-05-17
00858293006373E-Z Chek5116AK100-01172017-03-07
00858293006380EZ-Chek5100AK100-0101B2017-03-07
00858293006885Spiral Coil Tubing, Clear1W-013-102021-05-17
00858293006892Spiral Coil Tubing, Trans RedPU532-8WD02021-05-17
00858293006861Sani-lok Blood Port Barrier Adaptor7000-10502021-05-13
00858293006878Sani-lok Blood Port Barrier Adaptor7000-10502021-05-13
00858293006700Spiral Tubing, Trans Red1W-013-252019-08-30
00858293006717Spirial Tubing, Trans Blue1W-013-272019-08-30
00858293006724Spiral Coil Tubing Clear1W-025-102019-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102159Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102166Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102173Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102197Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102203Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102210Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782101459Prosphyg™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
00634782102180Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
06975185470358LightningWenzhou Kangshun Medical Devices CO.,LTDDXQ2026-08-08
06971996170005MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170012MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170029MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170036MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170043MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170050MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170067MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170074MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170081MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170098MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170104MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170111MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170128MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170135MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170142MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170159MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170166MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170173MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170180MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170197MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170203MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07