SOFT-CUF

GUDID 00840682107488

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff, reusable

Primary Device ID	00840682107488
NIH Device Record Key	caaab48f-4ae9-4594-a967-56e972f9a72c
Commercial Distribution Status	In Commercial Distribution
Brand Name	SOFT-CUF
Version Model Number	SFT-P2-2A
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	true
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
Phone	+1(800)558-5120
Email	xx@xx.xx

Device Dimensions

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682107105 [Primary]
GS1	00840682107488 [Package] Contains: 00840682107105 Package: [20 Units] In Commercial Distribution

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	4
Public Version Date	2019-07-22
Device Publish Date	2016-06-30

On-Brand Devices [SOFT-CUF]

00840682108164	2505
00840682107501	2363
00840682107426	2364
00840682107297	2140-INT
00840682107365	2362-INT
00840682107464	SFT-A3-2A
00840682107211	SFT-A2-2A-L
00840682107488	SFT-P2-2A
00840682107372	SFT-A1-2A
00840682107358	SFT-A2-2A
00840682107280	2116-INT
00840682108034	2404-INT
00840682107303	SFT-A3-2A-INT
00840682107518	2363-INT
00840682107440	2403
00840682107839	2506
00840682107792	2324
00840682107563	SFT-A2-2A-L-INT
00840682107679	2141
00840682107549	2364-INT
00840682107327	SFT-P2-2A-INT
00840682107648	2323
00840682107334	SFT-A2-2A-INT
00840682107341	2504
00840682107532	2403-INT
00840682107471	2140
00840682115513	2604
00840682107389	2126
00840682107228	2604-INT
00840682107525	2503-INT
00840682107587	2325
00840682107778	2365
00840682107631	2321
00840682107884	2507
00840682107242	2404
00840682107433	2362
00840682107310	2405-INT
00840682107686	2322
00840682107402	2502-INT
00840682107273	2405
00840682107495	2125
00840682107457	2124
00840682107570	2117
00840682107747	2361
00840682107693	2360
00840682107730	2320
00840682107785	2644
00840682107266	SFT-A1-2A-INT
00840682107235	2116
00840682107259	2503

Trademark Results [SOFT-CUF]

Mark Image Registration \| Serial	Company Trademark Application Date
SOFT-CUF 75722565 2505153 Live/Registered	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 1999-06-08
SOFT-CUF 72383708 0964918 Dead/Expired	FOREGGER COMPANY, INC., THE 1971-02-12