FDA.reportPublic FDA data

EXANOVO

Primary DI
06970691000068
Brand
EXANOVO
Company
Wuxi Exanovo Medical Instrument Co., Ltd.
Model
MC-50
Device description
with stethoscope
Published
2021-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff
LDEStethoscope, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2
LDEStethoscope, ManualCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203620000Aneroid SphygmomanometerWuxi Exanovo Medical Instrument Co., Ltd.2021-03-23DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970691000068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970691000068069706910000686970691000068

GMDN Terms#

Term, Definition table
TermDefinition
Aneroid manual sphygmomanometerA device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
541561271
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970691000013EXANOVOMC-2302021-05-08
06970691000020EXANOVOMC-2202021-05-08
06970691000075EXANOVOMC-4102021-05-08
06970691003076EXANOVOMC-5002021-05-08
06970691000273PRIMACAREKB-9181-RD2023-04-19
06970691000211PRIMACAREDS-9181-BK2023-04-10
06970691000228PRIMACAREDS-9181-RD2023-04-10
06970691000235PRIMACAREDS-9181-BL2023-04-10
06970691000242PRIMACAREDS-9197-BK2023-04-10
06970691000259PRIMACAREDS-9197-BL2023-04-10
06970691000266PRIMACAREDS-91952023-04-10
06970691000037EXANOVOMC-20A2021-05-08
06970691000044EXANOVOMC-20B2021-05-08
06970691000051EXANOVOMC-302021-05-08

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
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
M368201BKX1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10
08809209590815InBodyInBody Co., Ltd.DXQ2022-07-25
08809209590822InBodyInBody Co., Ltd.DXQ2022-07-25
10190752148529BroselowVYAIRE MEDICAL, INC.DXQ2022-04-04
10190752148543BroselowVYAIRE MEDICAL, INC.DXQ2022-04-04
10080196358649MedlineMEDLINE INDUSTRIES, INC.DXQ2022-03-31
M3687111001LABTRONGF HEALTH PRODUCTS, INC.LDE2021-08-24
10190752148536BROSELOW™VYAIRE MEDICAL, INC.DXQ2021-07-20
10080196172269MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DXQ2021-05-19
10080196358779MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DXQ2021-05-19
10080196172245MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DXQ2021-05-18
10080196357659MedlineMEDLINE INDUSTRIES, INC.DXQ2021-03-24
10080196358731MedlineMEDLINE INDUSTRIES, INC.DXQ2021-02-03
10080196172382MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DXQ2020-12-16
10080196172399MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DXQ2020-12-16