00840682119030 Medical Device Identification

GUDID 00840682119030

SOFT-CUF, LARGE ADULT LONG, 2 TB INFLATION SYSTEM, 31 - 40 CM, SINGLE

Ge Medical Systems Information Technologies, Inc.

Blood pressure cuff, reusable

Primary Device ID	00840682119030
NIH Device Record Key	fdcacd0a-8d23-473d-9e80-ed28a31abf27
Commercial Distribution Status	In Commercial Distribution
Version Model Number	002585
Company DUNS	118935631
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

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682119030 [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	6
Public Version Date	2025-05-22
Device Publish Date	2016-06-24

Devices Manufactured by Ge Medical Systems Information Technologies, Inc.

00195278343383 - CARESCAPE CENTRAL STATION	2026-02-19 MAI800 MEDICAL DEVICE
00195278343512 - CARESCAPE CENTRAL STATION	2026-02-19 MAS800 MEDICAL DEVICE
00198953107263 - MAC	2026-02-04 MAC VU360 V3.00 SW UPGRADE
00195278990914 - Portrait CSSXB	2025-12-18 PORTRAIT CORE SERVICES SOFTWARE V1.2.0
00198953024096 - Portrait CVAXB	2025-12-18 Portrait Central Viewer Application Installer V1.2.0
00840682144292 - CARESCAPE	2025-06-12 V100 GENERIC ATO MODEL No CE
00840682119030 - NA	2025-05-22SOFT-CUF, LARGE ADULT LONG, 2 TB INFLATION SYSTEM, 31 - 40 CM, SINGLE
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