FDA.reportPublic FDA data

NA

Primary DI
00840682118910
Brand
NA
Company
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Model
2059291-001
Device description
Y-ADAPTER 1 TB BAYONET MALE TO 2 TB DINACLICK FEM, SINGLE
Published
2016-07-15
Public version status
Update
Distribution status
Not 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
K120125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120125000SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUFGe Medical Systems Information Technologies, Inc.2012-10-03DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682118910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682118910008406821189108406821189100840682118910

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-5120xx@xx.xx

Regulatory Flags#

DUNS number
784985108
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278620873MAC72119091-0012026-03-31
00840682122504N/A420915-0692016-12-14
00840682122528N/A420915-0112016-12-13
00195278507037Mac-LabAltiX2300000-0032026-03-26
00195278507044CardioLabAltiX2300000-0042022-05-01
00195278507051ComboLabAltiX2300000-0052022-05-01
00195278507525MLCL Client SoftwareAltiX58896052022-05-01
00195278516015MLCL UpgradeAltiX58965972022-05-01
00195278330413Portrait CVA01CVA0158637212023-09-01
00195278341129Portrait CSS01CSS0158708572023-09-01
00840682104814NA2017098-0072016-07-22
00840682104845NA2017098-0032016-07-22
00840682104852NA2017098-0012016-07-22
00840682104869NA2017098-0052016-07-22
00840682109260CARESCAPETelemetry Server V42016-06-10
00840682104784N/APatient Data Module2016-05-27
00840682108775CARESCAPETelemetry Server v4 upgrade2016-06-10
00840682108799ApexPro600 MHz Receiver2016-06-10
00840682108928ApexProCH Transmitter2016-06-10
00840682109024ApexProFH Transceiver2016-06-10

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