SHERPA NX BALANCED

GUDID 20613994846444

CATHETER SB6JL505 SB 6F 5PK 100CM JL50

MEDTRONIC, INC.

Vascular guide-catheter, single-use

Primary Device ID	20613994846444
NIH Device Record Key	ab4a829d-2e9d-4c9b-8fb3-169552b8af21
Commercial Distribution Discontinuation	2017-08-02
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	SHERPA NX BALANCED
Version Model Number	SB6JL505
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

Length	100 Centimeter
Length	100 Centimeter
Length	100 Centimeter
Length	100 Centimeter
Length	100 Centimeter
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter
Catheter Gauge	6 French
Device Size Text, specify	0
Length	100 Centimeter

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	00613994846440 [Primary]
GS1	20613994846444 [Package] Contains: 00613994846440 Package: PK [5 Units] Discontinued: 2017-08-02 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K042489

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	2016-06-12

On-Brand Devices [SHERPA NX BALANCED]

00613994905314	CATHETER SB6PAPA1 SB 6F 100CM PAPA1
00613994905307	CATHETER SB6PAPA SB 6F 100CM PAPA
00613994846457	CATHETER SB7AR20A SB 7F 110CM AR20
20613994846444	CATHETER SB6JL505 SB 6F 5PK 100CM JL50
00613994842428	CATHETER SB7LCBA SB 7F 110CM LCB
00613994842411	CATHETER SB7JR40A SB 7F 110CM JR40
00613994842404	CATHETER SB7JL40A SB 7F 110CM JL40
00613994842398	CATHETER SB7AL20A SB 7F 110CM AL20
00613994837776	CATHETER SB7EBUL35 SB 7F 100CM EL35
00613994837769	CATHETER SB7EBUL35SH SB 7F 100CM EL35
00613994837752	CATHETER SB7EBUL375 SB 7F 100CM EL375
00613994837745	CATHETER SB7EBUL375SH SB 7F 100CM EL375
00613994837738	CATHETER SB7EBUL40 SB 7F 100CM EL40
00613994837721	CATHETER SB7EBUL40SH SB 7F 100CM EL40
00613994837714	CATHETER SB7EBUL45 SB 7F 100CM EL45
00613994837707	CATHETER SB7EBUL45SH SB 7F 100CM EL45
00613994837691	CATHETER SB7EBUL50 SB 7F 100CM EL50
00613994837684	CATHETER SB7EBUL50SH SB 7F 100CM EL50
00613994837677	CATHETER SB7ECR35 SB 7F 100CM ECR35
00613994837660	CATHETER SB7ECR35SH SB 7F 100CM ECR35
00613994837653	CATHETER SB7ECR40 SB 7F 100CM ECR40
00613994837646	CATHETER SB7ECR40SH SB 7F 100CM ECR40
00613994837639	CATHETER SB7ECR45 SB 7F 100CM ECR45
00613994837622	CATHETER SB7ECR45SH SB 7F 100CM ECR45
00613994837615	CATHETER SB7ELGAMAL SB 7F 100CM EG
00613994837608	CATHETER SB7EBUL30SH SB 7F 100CM EL30
00613994837592	CATHETER SB7EBU35 SB 7F 100CM EB35
20613994837589	CATHETER SB7EBU355 SB 7F 100CM 5PK EB35
00613994837578	CATHETER SB7EBU35SH SB 7F 100CM EB35
00613994837561	CATHETER SB7EBU35SHD SB 7F 90CM EB35
00613994837554	CATHETER SB7EBU375 SB 7F 100CM EB375
00613994837547	CATHETER SB7EBU375SH SB 7F 100CM EB375
00613994837530	CATHETER SB7EBU375SHD SB 7F 90CM EB375
00613994837523	CATHETER SB7EBU40 SB 7F 100CM EB40
20613994837510	CATHETER SB7EBU405 SB 7F 100CM 5PK EB40
00613994837509	CATHETER SB7EBU40D SB 7F 90CM EB40
00613994837493	CATHETER SB7EBU40SH SB 7F 100CM EB40
00613994837486	CATHETER SB7EBU45 SB 7F 100CM EB45
20613994837473	CATHETER SB7EBU455 SB 7F 100CM 5PK EB45
00613994837462	CATHETER SB7EBU45SH SB 7F 100CM EB45
00613994837455	CATHETER SB7EBU50 SB 7F 100CM EB50
00613994837448	CATHETER SB7EBU50SH SB 7F 100CM EB50
00613994837431	CATHETER SB7EBUL30 SB 7F 100CM EL30
00613994837424	CATHETER SB7IMT SB 7F 100CM IMT
00613994837417	CATHETER SB7JCL30 SB 7F 100CM JCL30
00613994837400	CATHETER SB7JCL30SH SB 7F 100CM JCL30
00613994837394	CATHETER SB7JCL35 SB 7F 100CM JCL35
00613994837387	CATHETER SB7JCL35SH SB 7F 100CM JCL35
00613994837370	CATHETER SB7JCL40 SB 7F 100CM JCL40
00613994837363	CATHETER SB7JCL40SH SB 7F 100CM JCL40