ZINGER® MEDIUM

GUDID 00643169452657

GDWR ZNGRMS180HS ZINGERMS 5PK 180 ST HY

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00643169452657
• NIH Device Record Key: e3e172a2-3295-4d8e-b09a-b25b00742bd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZINGER® MEDIUM
• Version Model Number: ZNGRMS180HS
• 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

Device Dimensions

• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169452657 [Primary]
GS1	20643169452651 [Package]; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140695

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-25

On-Brand Devices [ZINGER® MEDIUM]

• 20643169452668: GDWR ZNGRMS180HJ ZINGERMS 5PK 180 J HY
• 00643169452657: GDWR ZNGRMS180HS ZINGERMS 5PK 180 ST HY
• 00643169452640: GDWR ZNGRMS180J ZINGERMS 5PK 180 J SIL
• 00643169452633: GDWR ZNGRMS180S ZINGERMS 5PK 180 ST SIL
• 20643169452620: GDWR ZNGRMS300HJ ZINGERMS 5PK 300 J HY
• 20643169452613: GDWR ZNGRMS300HS ZINGERMS 5PK 300 ST HY
• 20643169452606: GDWR ZNGRMS300J ZINGERMS 5PK 300 J SIL
• 00643169452596: GDWR ZNGRMS300S ZINGERMS 5PK 300 ST SIL
• 20643169452316: GDWR LVZRMS180J ZINGRMS CRM 5PK 180 J HY
• 20643169452309: GDWR LVZRMS180S ZINGRMS CRM 5PK 180 S HY
• 20763000569604: GDWR ZNGRMS180HJ ZINGERMS 5PK 180 J HY
• 20763000569598: GDWR ZNGRMS180HS ZINGERMS 5PK 180 ST HY
• 20763000569581: GDWR ZNGRMS180J ZINGERMS 5PK 180 J SIL
• 20763000569574: GDWR ZNGRMS180S ZINGERMS 5PK 180 ST SIL
• 20763000569567: GDWR ZNGRMS300HJ ZINGERMS 5PK 300 J HY
• 20763000569550: GDWR ZNGRMS300HS ZINGERMS 5PK 300 ST HY
• 20763000569543: GDWR ZNGRMS300J ZINGERMS 5PK 300 J SIL
• 20763000569536: GDWR ZNGRMS300S ZINGERMS 5PK 300 ST SIL