N/A ZDC4301F-1

GUDID 10607411951296

DuraCheck Blood pressure cuff, reusable, adult - Single Tube

SALTER LABS

Blood pressure cuff, single-use
Primary Device ID10607411951296
NIH Device Record Keyec49b41e-5777-4bc2-846c-384f57f3be19
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberZDC4301F-1
Catalog NumberZDC4301F-1
Company DUNS022721133
Company NameSALTER LABS
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100607411951299 [Primary]
GS110607411951296 [Package]
Contains: 00607411951299
Package: [5 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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-12

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