FDA.reportPublic FDA data

Caremed

Primary DI
06970758507806
Brand
Caremed
Company
Shenzhen Caremed Medical Technology Co., Ltd.
Model
N2S11-10
Catalog number
N2S11-10
Device description
Caremed NIBP Cuff
Published
2019-11-01
Public version status
New
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
K182433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182433000Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffShenzhen Caremed Medical Technology Co., Ltd.2018-12-17DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970758507806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970758507806069707585078066970758507806

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

Regulatory Flags#

DUNS number
544335718
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970758507707CaremedSA11Y-49SA11Y-492019-11-01
06970758507691CaremedSA30Y-15RSA30Y-15R2019-10-30
06970758500029CaremedReusable2017-12-08
06970758500159CaremedC403-012018-02-03
06970758500166CaremedC403S-152018-02-03
06970758500173CaremedN543-012018-02-03
06970758507608CaremedPWC10-LB-APWC10-LB-A2019-11-01
06970758507622CaremedEHP3R-90P-AEHP3R-90P-A2019-11-01
06970758507639CaremedEHP5R-90P-AEHP5R-90P-A2019-11-01
06970758507646CaremedEHPU385-AEHPU385-A2019-11-01
06970758507677CaremedEHPU585-AEHPU585-A2019-10-31
06970758507615Caremed AD-BA-10AD-BA-102019-10-30
06970758500012Caremedcable2017-12-08
06970758500098CaremedMQB5-90S2018-02-06
06970758500104Caremed2585P2018-02-06
06970758500111CaremedMQ-25862018-02-06
06970758500128CaremedE10R-SH1-N2018-02-06
06970758500135CaremedE10R-MQ2018-02-06
06970758500142CaremedMQ10-LN2018-02-06
06970758507721CaremedTZDHP-PHTZDHP-PH2019-11-01

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