Vinyl Cuff

GUDID 20840935108310

SUNTECH MEDICAL, INC.

Blood pressure cuff, reusable
Primary Device ID20840935108310
NIH Device Record Key45782e9e-1121-4f6e-ae95-77b89ccb10e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameVinyl Cuff
Version Model Number98-0799-4K
Company DUNS148191133
Company NameSUNTECH MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110840935108313 [Primary]
GS120840935108310 [Package]
Contains: 10840935108313
Package: Box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXQBlood Pressure Cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-22
Device Publish Date2018-12-07

On-Brand Devices [Vinyl Cuff]

2084093510831098-0799-4K
2084093510830398-0799-3K
2084093510829798-0799-2K
2084093510828098-0799-1K
2084093510827398-0799-0K

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