Versa®

GUDID 00643169474277

IPG VEDR01 VERSA US MKT

MEDTRONIC, INC.

Dual-chamber implantable pacemaker, rate-responsive
Primary Device ID00643169474277
NIH Device Record Keye99b425a-a5c4-494c-9a54-6b02c3d92b2f
Commercial Distribution Discontinuation2019-08-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVersa®
Version Model NumberVEDR01
Company DUNS006261481
Company NameMEDTRONIC, 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 Usetrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
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 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169474277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWPImplantable pulse generator, pacemaker (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-01
Device Publish Date2015-02-05

Devices Manufactured by MEDTRONIC, INC.

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00199150006878 - NA2025-04-22 CUSTOM PACK BB6Y37R3 CP PRIME
20199150006896 - NA2025-04-22 CUSTOM PACK BB10Y97R1 5PK MANIFOLD
20199150006919 - NA2025-04-22 CUSTOM PACK BB10Y99R1 10PK ARTERIAL Y
00199150006922 - NA2025-04-22 CUSTOM PACK BB11Q27R2 MANIFOLD

Trademark Results [Versa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERSA
VERSA
98889485 not registered Live/Pending
Alamo Group Inc.
2024-12-06
VERSA
VERSA
98764709 not registered Live/Pending
Medical Positioning, Inc.
2024-09-23
VERSA
VERSA
98677016 not registered Live/Pending
Versa Mobility LLC
2024-07-31
VERSA
VERSA
98622807 not registered Live/Pending
Versaware Technologies, Inc.
2024-06-27
VERSA
VERSA
98499174 not registered Live/Pending
Island Creek Boat Company
2024-04-14
VERSA
VERSA
98364968 not registered Live/Pending
Singh, Sarvinder
2024-01-19
VERSA
VERSA
98338114 not registered Live/Pending
Handrail Design, Inc.
2024-01-02
VERSA
VERSA
98306442 not registered Live/Pending
JP COMMERCE, LLC
2023-12-08
VERSA
VERSA
98281520 not registered Live/Pending
De, Subrata
2023-11-22
VERSA
VERSA
98262679 not registered Live/Pending
Britax Child Safety, Inc.
2023-11-09
VERSA
VERSA
98232272 not registered Live/Pending
Tech1 Corporation
2023-10-19
VERSA
VERSA
97977858 not registered Live/Pending
Power Gripps, USA, Inc.
2023-03-07

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