Guardian™ Link (3)

GUDID 00643169955691

XMTR MMT-7811NA GST3C LOCKOUT US

MEDTRONIC MINIMED, INC.

Ambulatory insulin infusion pump, electronic

• Primary Device ID: 00643169955691
• NIH Device Record Key: a94469cd-8ed8-4967-a83a-c82222c4a33f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian™ Link (3)
• Version Model Number: MMT-7811NA
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: true

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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169955691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160017

FDA Product Code

• OZP: Artificial pancreas device system, single hormonal control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2017-10-30

On-Brand Devices [Guardian™ Link (3)]

• 00643169955691: XMTR MMT-7811NA GST3C LOCKOUT US
• 00763000215538: RPL MMT-7811NA GST3C LOCKOUT 2.2A ARM
• 00763000166540: RPL MMT-7811NA GST3C LOCKOUT 2.1C ARM
• 00763000146849: XMTR MMT-7811NA GST3C LOCKOUT V2.1C
• 00763000286781: KIT MMT-7810PNA XMTR GST3C 2.2A RX
• 00763000286774: KIT MMT-7810PN1 XMTR GST3C 2.1C RX
• 00763000239831: RPL MMT-7811N1 GST3C LOCKOUT 2.1C ARM
• 00763000239824: STRT KIT MMT-7810N1 XMTR GST3C 2.1C ARM
• 00763000400620: RPL MMT-7811NA GST3C LOCKOUT 2.2A ARM CD
• 00763000386986: STRT KIT MMT-7810PNA GST3C 2.2A RX CD
• 00763000316990: STARTER KIT MMT-7910NA ASSY GST5C US
• 00763000391065: KIT ASSY PKG MMT-7811NA INTRICON
• 00763000391034: KIT ASSY PKG MMT-7810PNA INTRICON US
• 00763000372002: REPLACEMENT MMT-7911NA ASSY GST5C US
• 00763000521363: KIT MMT-7910MNA ASSY GST5C US MEDICARE
• 00763000386979: STRT KIT MMT-7810N1 GST3C 2.1C ARM CD
• 00763000357511: STARTER KIT MMT-7910PNA ASSY GST5C RX