FDA.report

Technicuff

Primary DI
00819980010028
Brand
Technicuff
Company
TECHNICUFF CORP.
Model
UT-3962
Device description
Bariatric Blood Pressure Cuff 25 each
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DXQBlood Pressure Cuff

Product Code Classifications

CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions

SubmissionSupplement
K942259000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K942259000TECHNICUFFTechnicuff Corp.1994-09-06DXQ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819980010028PrimaryGS10

GMDN Terms

TermDefinition
Patient monitoring system module, blood pressure, noninvasiveA small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.

Sterilization Methods

Method

Regulatory Flags

DUNS number
148745805
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00819980010011TechnicuffUT-39622016-09-14
00819980010080TechnicuffUA-17452016-09-14
00819980010097TechnicuffUA-17452016-09-14
00819980010103TechnicuffUA-17452016-09-14
00819980010158TechnicuffUP-09252016-09-14
00819980010165TechnicuffUP-09252016-09-14
00819980010226TechnicuffUI-05152016-09-14
00819980010233TechnicuffUI-05152016-09-14
00819980010295TechnicuffUN-03142016-09-14
00819980010301TechnicuffUN-03142016-09-14
00819980010363TechnicuffUN-03092016-09-14
00819980010370TechnicuffUN-03092016-09-14
00819980010417TechnicuffUA-E2016-09-14
00819980010424TechnicuffUA-E2016-09-14
00819980010431TechnicuffUT-3962L2016-09-14
00819980010448TechnicuffUT-3962L2016-09-14
00819980010509TechnicuffUA-1745L2016-09-14
00819980010516TechnicuffUA-1745L2016-09-14
00819980010523TechnicuffUA-1745L2016-09-14
00819980010578TechnicuffUP-0925L2016-09-14

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