FDA.reportPublic FDA data

MDF®

Primary DI
06940211628980
Brand
MDF®
Company
MDF Instruments Medifriend Inc.
Model
MDF848XPD12
Device description
AAneroid Sphygmomanometer, Single Bellow, MDF12
Published
2018-12-31
Public version status
Update
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
06940211628980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06940211628980069402116289806940211628980

GMDN Terms#

Term, Definition table
TermDefinition
Aneroid manual sphygmomanometerA device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.

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
06940211627693MDF®MDF808M04KT22018-12-31
06940211627709MDF®MDF808MBOKT22018-12-31
06940211627761MDF®MDF808042018-09-30
06940211627969MDF®MDF808MBOKT12018-12-31
06940211628010MDF®MDF808B042018-12-31
06940211628027MDF®MDF808B082018-12-31
06940211628034MDF®MDF808B112018-12-31
06940211628041MDF®MDF808B122018-12-31
06940211628058MDF®MDF808B142018-12-31
06940211628065MDF®MDF808BBO2018-12-31
06940211628089MDF®MDF808B162018-12-31
06940211628096MDF®MDF808M042018-12-31
06940211628102MDF®MDF808M082018-12-31
06940211628119MDF®MDF808M112018-09-30
06940211628126MDF®MDF808M08KT12018-12-31
06940211628133MDF®MDF808M11KT12018-12-31
06940211628140MDF®MDF808M32KT12018-12-31
06940211628157MDF®MDF808M08KT22018-12-31
06940211628164MDF®MDF808M11KT22018-12-31
06940211628188MDF®MDF808B322018-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102524Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-10-16
00634782102449Multikuf™AMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782101725Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-03-30
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
06940211628515MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628522MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628539MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628546MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628584MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628669MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628676MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31