HMS PLUS

GUDID 00763000158002

INST PKGD DOMESTIC 30514 HMS PLUS 511

MEDTRONIC, INC.

Coagulation timer IVD

• Primary Device ID: 00763000158002
• NIH Device Record Key: 44c5280b-8f12-475f-8868-5d83201fd359
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMS PLUS
• Version Model Number: 30514
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000158002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101271

FDA Product Code

• JOX: ANALYZER, HEPARIN, AUTOMATED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-04
• Device Publish Date: 2019-02-01

On-Brand Devices [HMS PLUS]

• 00613994909404: RECONDITION HMS PLUS R30514AM
• 00681490512084: INSTRUMENT R30514 HMS PLUS RECON
• 00673978698793: INSTRUMENT 30514 HMS PLUS 110V EN
• 00721902433719: RESERVOIR 31506 HMS
• 00885074092904: INSTRUMENT E30514 HMS + EVAL UNIT
• 00763000158002: INST PKGD DOMESTIC 30514 HMS PLUS 511