FDA.reportPublic FDA data

Technicuff

Primary DI
00819980010301
Brand
Technicuff
Company
TECHNICUFF CORP.
Model
UN-0314
Device description
Neonatal 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

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
K942259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942259000TECHNICUFFTechnicuff Corp.1994-09-06DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819980010301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819980010301008199800103018199800103010819980010301

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819980010011TechnicuffUT-39622016-09-14
00819980010028TechnicuffUT-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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782902636Adcuff™ AMERICAN DIAGNOSTIC CORPDXQ2026-02-23
M3681097002GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682338A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682338X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452C1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823481A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823552N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823552X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562C1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823572A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682360A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682362X2GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
00810079260089Teladoc Health, Inc.Teladoc Health, Inc.DXQ2026-02-17
16978034830133tenoviShenzhen Jamr Medical Technology Co., Ltd.DXQ2025-12-12
16978034830140tenoviShenzhen Jamr Medical Technology Co., Ltd.DXQ2025-12-12
10840935111702Straight Black Hose, Female Bayonet to Female Bayonet, 9.8ft (3m), SiemensSUNTECH MEDICAL, INC.DXQ2025-12-01
10840935111719Straight Gray Hose, Female Luer to Female Bayonet, 9.8ft (3m), SiemensSUNTECH MEDICAL, INC.DXQ2025-12-01
10840935111696Patient HoseSUNTECH MEDICAL, INC.DXQ2025-11-18
20197344165343MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
20197344165374MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
20197344165398MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165339MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165353MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165360MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165384MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14