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

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 ID	00840682118910
NIH Device Record Key	2f448261-db7e-4a9f-ac16-df1d1cc24b08
Commercial Distribution Discontinuation	2025-04-01
Commercial Distribution Status	Not in Commercial Distribution
Version Model Number	2059291-001
Company DUNS	784985108
Company Name	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682118910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K120125

FDA Product Code

DXQ	blood pressure cuff

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	7
Public Version Date	2025-05-02
Device Publish Date	2016-07-15

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

00840682119030 - NA	2025-05-22 SOFT-CUF, LARGE ADULT LONG, 2 TB INFLATION SYSTEM, 31 - 40 CM, SINGLE
00840682119085 - NA	2025-05-22 SOFT-CUF, SMALL ADULT, 2 TB INFLATION SYSTEM, 17 - 25 CM, SINGLE
00840682106009 - SOFT-CUF	2025-05-16 SOFT-CUF, NEONATAL1, 2 TB MALE SLIP, 03 - 06 CM, SINGLE
00840682106122 - SOFT-CUF	2025-05-16 SOFT-CUF, NEONATAL2, 1 TB MALE SLIP, 04 - 08 CM, SINGLE
00840682106146 - SOFT-CUF	2025-05-16 SOFT-CUF, NEONATAL1, 1 TB MALE SLIP, 03 - 06 CM, SINGLE
00840682106160 - SOFT-CUF	2025-05-16 SOFT-CUF, NEONATAL4, 2 TB MALE SLIP, 07 - 13 CM, SINGLE
00840682106207 - SOFT-CUF	2025-05-16 SOFT-CUF, NEONATAL5, 2 TB MALE SLIP, 08 - 15 CM, SINGLE
00840682106269 - SOFT-CUF	2025-05-16 SOFT-CUF, NEONATAL3, 2 TB MALE SLIP, 06 - 11 CM, SINGLE