MY-CUF

GUDID 00840682116947

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff, single-use
Primary Device ID00840682116947
NIH Device Record Key0c44d7d8-630c-4854-96ee-a359f97fe969
Commercial Distribution StatusIn Commercial Distribution
Brand NameMY-CUF
Version Model NumberMY-T1-2A
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682116220 [Primary]
GS100840682116947 [Package]
Contains: 00840682116220
Package: [20 Units]
In Commercial Distribution

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 Number3
Public Version Date2018-07-06
Device Publish Date2017-03-15

On-Brand Devices [MY-CUF]

00840682116954MY-P1-2A
00840682116466MY-A3-1B
00840682116893MY-A2-2E-L
00840682116930MY-P1-2C
00840682116497MY-T1-1B
00840682116435MY-A1-2C
00840682120920MY-A2-2A
00840682120913MY-A2-2C-L
00840682116381MY-P1-1B
00840682120876MY-A3-2E
00840682116947MY-T1-2A
00840682116428MY-A1-2A
00840682116374MY-T1-2E
00840682120890MY-T1-2C
00840682116961MY-A3-2C
00840682120944MY-P2-2C
00840682120883MY-P2-2A
00840682116459MY-A2-1B-L
00840682120968MY-P2-2E
00840682120951MY-P1-2E
00840682116916MY-A3-2A
00840682120937MY-A2-2E
00840682120906MY-A1-2E
00840682116480MY-P2-1B
00840682116411MY-A2-1B
00840682116909MY-A2-2C
00840682116923MY-A2-2A-L
00840682116398MY-A1-1B

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.