GUDID 00643169838482

BP CUFF REGULAR SMALL BP-D01

Medtronic Care Management Services, LLC

Blood pressure cuff, reusable
Primary Device ID00643169838482
NIH Device Record Keyacd1e9f3-119e-4cdb-8eee-e138486fd274
Commercial Distribution StatusIn Commercial Distribution
Version Model Number450001-014
Company DUNS061079989
Company NameMedtronic Care Management Services, LLC
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169838482 [Primary]

FDA Product Code

DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-22
Device Publish Date2016-09-08

Devices Manufactured by Medtronic Care Management Services, LLC

00643169838482 - NA2019-07-22BP CUFF REGULAR SMALL BP-D01
00643169838482 - NA2019-07-22 BP CUFF REGULAR SMALL BP-D01
00643169838499 - NA2019-07-22 BP CUFF REGULAR MEDIUM BP-D02
00643169838505 - NA2019-07-22 BP CUFF REGULAR LARGE BP-D03
00643169838512 - NA2019-07-22 BP CUFF CONTOUR MEDIUM BP-D02
00643169838529 - NA2019-07-22 BP CUFF CONTOUR LARGE BP-D03
00763000286972 - Commander Flex™2019-07-16 HUB CD320 CMDR FLEX - GA
00763000286989 - Commander Flex™2019-07-16 HUB CD320 CMDR FLEX - CA
00763000286996 - Commander Flex™2019-07-16 HUB CD320 CMDR FLEX - CV

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