FDA.reportPublic FDA data

Amico Diagnostic Cuff

Primary DI
00697077002510
Brand
Amico Diagnostic Cuff
Company
Amico Diagnostic Incorporated
Model
CR2-LF07O-2QFQM
Device description
Infant 2-Piece Cuff, 2 Tubes LF, Orange, Quick Connect Male & Female Connector
Published
2020-07-17
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
00697077002510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00697077002510006970770025106970770025100697077002510

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
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
00697077001438Amico Diagnostic StationDS-UF1-CHFH-DLO2016-09-24
00697077001469Amico Diagnostic StationDS-UF1-CLFL-DAO2016-09-24
00697077001476Amico Diagnostic StationDS-UF1-CLFL-DLO2016-09-24
00697077001490Amico Diagnostic Wallboard DS-ULG-CHFH-DAO2016-09-24

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