FDA.reportPublic FDA data

Amico Diagnostic Cuff

Primary DI
00697077002244
Brand
Amico Diagnostic Cuff
Company
Amico Diagnostic Incorporated
Model
CR2-LF11N-2BVSM
Device description
Adult 2-Piece Cuff, 2 Tube LF, Maroon, Infl Bulb x Screw Male
Published
2017-09-08
Public version status
Update
Distribution status
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
K012444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012444000ABN ANEROID SPHYGMOMANOMETERPt. Sugih Instrumendo Abadi2001-08-16DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00697077002244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00697077002244006970770022446970770022440697077002244

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff inflator, manualA bulb-like device intended to be used to manually inflate the cuff of a manual sphygmomanometer. It is connected to one of the connectors of the cuff and the operator manually pumps air into the cuff by continually squeezing this device until the desired pressure within the cuff has been reached. It will typically consist of a rubber bulb, a one-way valve that draws in ambient air, and a release valve used by the operator to slowly release the pressure in the complete sphygmomanometer/cuff/inflator system so that blood pressure can be measured. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-462-6426info@amico-accessories.com

Regulatory Flags#

DUNS number
203163290
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00697077003180Amico Diagnostic CuffCR2-LF09G-2QFQF2026-07-07
00697077003197Amico Diagnostic CuffCR2-LF10B-2QFQF2026-07-07
00697077003203Amico Diagnostic CuffCR2-LF13W-2QFQF2026-07-07
00697077003210Amico Diagnostic CuffCR2-LF11N-2QFQF2026-07-07
00697077003081Amico Diagnostic StationDS-KDM-CLFL-DAO 2025-07-14
00697077002565Amico Diagnostic StationDS-UF2-CHFH-DAO2020-07-17
00697077002527Amico Diagnostic StationDS-UF3-CHFH-DAO2020-02-24
00697077002480Amico Diagnostic RollstandDS-UR1-CLFL-DAO2019-03-26
00697077001070Amico Diagnostic StationDS-UA1-CHFH-DAO2016-09-24
00697077001100Amico Diagnostic StationDS-UA1-CHFH-DLO2016-09-24
00697077001124Amico Diagnostic StationDS-UA1-CHFH-DXO2016-09-24
00697077001155Amico Diagnostic StationDS-UA1-CLFL-DAO2016-09-24
00697077001162Amico Diagnostic StationDS-UA1-CLFL-DLO2016-09-24
00697077001209Amico Diagnostic Wallboard DS-UBW-CHFH-DAO2016-09-24
00697077001230Amico Diagnostic Wallboard DS-UBW-CLFL-DAO2016-09-24
00697077001254Amico Diagnostic StationDS-UDM-CHFH-DAO2016-09-24
00697077001322Amico Diagnostic StationDS-UDM-CLFL-DAO2016-09-24
00697077001377Amico Diagnostic Wallboard DS-UDN-CHFH-DAO2016-09-24
00697077001391Amico Diagnostic StationDS-UE1-CHFH-DLO2016-09-24
00697077001421Amico Diagnostic StationDS-UF1-CHFH-DAO2016-09-24

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