GUDID 00840682118910

Y-ADAPTER 1 TB BAYONET MALE TO 2 TB DINACLICK FEM, SINGLE

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff inflator, manual
Primary Device ID00840682118910
NIH Device Record Key2f448261-db7e-4a9f-ac16-df1d1cc24b08
Commercial Distribution Discontinuation2025-04-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number2059291-001
Company DUNS784985108
Company NameGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682118910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXQblood pressure cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2025-05-02
Device Publish Date2016-07-15

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

00840682119030 - NA2025-05-22 SOFT-CUF, LARGE ADULT LONG, 2 TB INFLATION SYSTEM, 31 - 40 CM, SINGLE
00840682119085 - NA2025-05-22 SOFT-CUF, SMALL ADULT, 2 TB INFLATION SYSTEM, 17 - 25 CM, SINGLE
00840682106009 - SOFT-CUF2025-05-16 SOFT-CUF, NEONATAL1, 2 TB MALE SLIP, 03 - 06 CM, SINGLE
00840682106122 - SOFT-CUF2025-05-16 SOFT-CUF, NEONATAL2, 1 TB MALE SLIP, 04 - 08 CM, SINGLE
00840682106146 - SOFT-CUF2025-05-16 SOFT-CUF, NEONATAL1, 1 TB MALE SLIP, 03 - 06 CM, SINGLE
00840682106160 - SOFT-CUF2025-05-16 SOFT-CUF, NEONATAL4, 2 TB MALE SLIP, 07 - 13 CM, SINGLE
00840682106207 - SOFT-CUF2025-05-16 SOFT-CUF, NEONATAL5, 2 TB MALE SLIP, 08 - 15 CM, SINGLE
00840682106269 - SOFT-CUF2025-05-16 SOFT-CUF, NEONATAL3, 2 TB MALE SLIP, 06 - 11 CM, SINGLE

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.