FDA.reportPublic FDA data

SOFT-CUF

Primary DI
00840682105446
Brand
SOFT-CUF
Company
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Model
SFT-F1-2C
Device description
SOFT-CUF, RADIAL, 2 TB SUBMIN, 26 - 36 CM, SINGLE
Published
2016-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXQblood pressure cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123996000RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFFGe Medical Systems Information Technologies, Inc.2013-04-09DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682105750PackageGS120Not in Commercial Distribution
00840682105446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682105750008406821057508406821057500840682105750
00840682105446008406821054468406821054460840682105446

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
784985108
Device count
1
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682105491SOFT-CUFSFT-F1-2E2016-06-30
00840682106818SOFT-CUF21262016-06-30
00840682107150SOFT-CUF2362-INT2362-INT2016-06-30
00840682108805CLASSIC-CUF23592016-06-30
00840682108874CLASSIC-CUF23582016-06-30
00840682109215CLASSIC-CUF21382016-06-30
00840682109291CLASSIC-CUF21332016-06-30
00840682109307CLASSIC-CUF21192016-06-30
00840682109437CLASSIC-CUF230723072016-06-30
00840682109635CLASSIC-CUF230223022016-06-30
00840682109710CLASSIC-CUF230523052016-06-30
00840682110778SENSA-CUF24702016-06-30
00840682110792SENSA-CUF24622016-06-30
00840682110822SENSA-CUF24642016-06-30
00840682110839SENSA-CUF24682016-06-30
00840682110846SENSA-CUF24742016-06-30
00840682110907SENSA-CUF24722016-06-30
00840682110914SENSA-CUF24662016-06-30
00840682110969SENSA-CUF24782016-06-30
00840682111270SENSA-CUF24762016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102524Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-10-16
00859140003200DealmedDEALMED MEDICAL SUPPLIES LLCDXQ2026-10-08
00859140003217DealmedDEALMED MEDICAL SUPPLIES LLCDXQ2026-10-08
00634782102449Multikuf™AMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782102517ADCAMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782102159Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102166Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102173Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102197Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102203Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102210Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782101459Prosphyg™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
00634782102180Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
06975185470358LightningWenzhou Kangshun Medical Devices CO.,LTDDXQ2026-08-08
06971996170005MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170012MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170029MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170036MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170043MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170050MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170067MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170074MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170081MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170098MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170104MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170111MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170128MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170135MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170142MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170159MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07