FDA.reportPublic FDA data

MDF®

Primary DI
06940211635360
Brand
MDF®
Company
MDF Instruments Medifriend Inc.
Model
MDF210045013
Device description
Blood Pressure Cuff, Adult, Double Tube, MDF13
Published
2026-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K950778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950778000MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETERShanghai Medifriend Medical Products Co., Ltd.1995-03-14DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06940211635360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06940211635360069402116353606940211635360

Regulatory Flags#

DUNS number
420328205
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06940211600016MDF®2700490T-1762026-11-03
06940211600023MDF®270427DT-1662026-11-03
06940211600641MDF®MDF797TCD292026-11-03
06940211600658MDF®MDF797TCD112026-11-03
06940211600665MDF®MDF797TTBCD2026-11-03
06940211600672MDF®MDF797TSNCD2026-11-03
06940211600689MDF®MDF797TPSCD2026-11-03
06940211600702MDF®MDF777TZBCD2026-11-03
06940211600719MDF®MDF777TPWCD2026-11-03
06940211600726MDF®MDF777TTDCD2026-11-03
06940211600733MDF®MDF777TCD112026-11-03
06940211600740MDF®MDF777TCD292026-11-03
06940211600894MDF®MDF797TBMKL2026-11-03
06940211600900MDF®MDF797TBMRG2026-11-03
06940211600931MDF®MDF797TPW2026-11-03
06940211602119MDF®MDF797TWSCD2026-11-03
06940211602126MDF®MDF797TGMRG2026-11-03
06940211602133MDF®MDF797TRLKL2026-11-03
06940211602140MDF®MDF797TPPBO2026-11-03
06940211602164MDF®MDF797TRPKL2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06940211621653MDF®MDF Instruments Medifriend Inc.DXQ2026-11-03
00634782102524Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-10-16
00634782102449Multikuf™AMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782101725Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-03-30
20884838114931NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDXQ2025-07-03
20884838114955NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDXQ2025-07-03
20884838114979NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDXQ2025-07-03
20884838114993NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDXQ2025-07-03
20884838115013NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDXQ2025-07-03
00884838114913NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDXQ2025-07-02
06940211627693MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627709MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627969MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628010MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628027MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628034MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628041MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628058MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628065MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628089MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628096MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628102MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628126MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628133MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628140MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628157MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628164MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628188MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628263MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628317MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31