Z2

GUDID 00613994810793

CATHETER Z27AR10D 7F 90CM AR10

MEDTRONIC, INC.

Vascular guide-catheter, single-use

Primary Device ID	00613994810793
NIH Device Record Key	59ac49c5-1a97-43d0-b257-9fd1eaa01c71
Commercial Distribution Status	In Commercial Distribution
Brand Name	Z2
Version Model Number	Z27AR10D
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0
Length	90 Centimeter
Catheter Gauge	7 French
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, Specify	Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994810793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K000677

FDA Product Code

DQY	CATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-01-23
Device Publish Date	2016-06-11

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00613994817457	CATHETER ZM5JCR50 Z2 5F 100CM JCR50
00613994817440	CATHETER ZM5JCR45 Z2 5F 100CM JCR45
00613994817433	CATHETER ZM5JCR40 Z2 5F 100CM JCR40
00613994817426	CATHETER ZM5JCR35 Z2 5F 100CM JCR35
00613994817419	CATHETER ZM5JCL50 Z2 5F 100CM JCL50
00613994817402	CATHETER ZM5JCL45 Z2 5F 100CM JCL45
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00613994817365	CATHETER ZM5IMAD Z2 5F 90CM IMA
00613994817358	CATHETER ZM5IMA Z2 5F 100CM IMA
00613994817341	CATHETER ZM5HSIII Z2 5F 100CM HSIII
00613994817334	CATHETER ZM5HSII Z2 5F 100CM HSII
00613994817327	CATHETER ZM5CHAMP05 Z2 5F 100CM CH05
00613994817310	CATHETER ZM5AR20 Z2 5F 100CM AR20
00613994817303	CATHETER ZM5AR10 Z2 5F 100CM AR10
00613994817297	CATHETER ZM5ALR12 Z2 5F 100CM ALR12
00613994817280	CATHETER ZM5AL75 Z2 5F 100CM AL75
00613994817273	CATHETER ZM5AL40 Z2 5F 100CM AL40
00613994817266	CATHETER ZM5AL30 Z2 5F 100CM AL30
00613994817259	CATHETER ZM5AL25 Z2 5F 100CM AL25
00613994817242	CATHETER ZM5AL20 Z2 5F 100CM AL20
00613994817235	CATHETER ZM5AL15 Z2 5F 100CM AL15
00613994817228	CATHETER ZM5AL10 Z2 5F 100CM AL10
00613994817211	CATHETER ZM53DRIGHT Z2 5F 100CM 3DRGT
00613994817204	CATHETER ZM53DRC Z2 5F 100CM 3DRC
00613994817198	CATHETER ZM5ELGAMAL Z2 5F 100CM EG
00613994817181	CATHETER ZM5EBU50 Z2 5F 100CM EB50
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00613994817167	CATHETER ZM5EBU40 Z2 5F 100CM EB40
00613994817150	CATHETER ZM5EBU375 Z2 5F 100CM EB375
00613994817143	CATHETER ZM5EBU35 Z2 5F 100CM EB35