FDA.reportPublic FDA data

STATCORP MEDICAL

Primary DI
10841522102592
Brand
STATCORP MEDICAL
Company
Statcorp Medical
Model
STATCORP
Catalog number
015-3242
Device description
ABP CUFF,SPACELABS,1T,LARGE ADULT,SINGLE
Published
2017-03-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K152801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152801000ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULTStatcorp Medical2015-10-27DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841522102596PackageGS120Not in Commercial Distribution
10841522102592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084152210259630841522102596
1084152210259210841522102592

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
602075905
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522112126SoftcheckSoftCheck BP Cuffs3009167-0302016-12-01
10841522112188SoftcheckSoftCheck BP Cuffs3009167-0342016-12-01
10841522109577UltracheckUltraCheck BP CuffsUS1826MB2016-10-24
10841522109638UltracheckUltraCheck BP CuffsUS3544MB2016-10-24
10841522109898UltracheckUltraCheck BP CuffsUD1826MQ2016-10-19
10841522110009UltracheckUltraCheck BP CuffsUD2938MQ2016-10-19
10841522110061UltracheckUltraCheck BP CuffsUD3242MQ2016-10-19
10841522106576Statcorp MedicalSTATCORPUD0814MQMF2016-10-04
10841522107665UltracheckUltraCheck BP CuffsUS4250DM2016-10-04
10841522108228SoftcheckSoftCheck BP CuffsNN4DT2016-11-10
10841522108310SoftcheckSoftCheck BP CuffsVDT3544DM2016-10-24
10841522109119SoftcheckSoftCheck BP CuffsST1826DM2016-10-04
10841522109225SoftcheckSoftCheck BP CuffsST2635DM2016-10-04
10841522109270UltracheckUltraCheck BP CuffsUS1320MML2016-10-24
10841522109263SoftcheckSoftCheck BP CuffsST2635ML2016-12-07
10841522109133UltracheckUltraCheck BP CuffsN/A2016-12-15
10841522130458TrulinkABP Cuffs and Cuff Covers715-3021-002025-03-13
10841522130465TrulinkABP Cuffs and Cuff Covers715-3022-002025-03-13
10841522130472TrulinkABP Cuffs and Cuff Covers715-3031-002025-03-13
10841522130489TrulinkABP Cuffs and Cuff Covers715-3032-002025-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344111565MEDLINEMEDLINE INDUSTRIES, INC.DXQ2026-05-21
M3681097001GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682362X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
10197344165346MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165377MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165391MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10326053121521Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121538Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121545Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121552Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121569Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121576Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121583Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121590Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121606Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121613Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121620Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121637Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121644Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121651Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121668Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121675Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121682Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121699Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121705Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10197344014514MEDLINEMEDLINE INDUSTRIES, INC.DXQ2024-09-02
10197344020645MedlineMEDLINE INDUSTRIES, INC.DXQ2024-03-27
M3682011GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10
M368201BK1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10
M368201BKC1GAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10