AMC&E

GUDID 30817357020480

AMC&E 5-lead DIN to Pinch Leadset

HYGIA HEALTH SERVICES, INC.

Electrocardiographic lead set, reprocessed

• Primary Device ID: 30817357020480
• NIH Device Record Key: cfe311b6-3d52-4793-a54e-add4d1365ecd
• Commercial Distribution Discontinuation: 2019-05-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AMC&E
• Version Model Number: LW-309DS50/5A
• Company DUNS: 177939027
• Company Name: HYGIA HEALTH SERVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817357020486 [Primary]
GS1	30817357020480 [Package]; Contains: 10817357020486; Package: Box [25 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Product Code

• IKD: Cable, Electrode

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-03-19
• Device Publish Date: 2016-09-30

On-Brand Devices [AMC&E]

• 30817357021241: AMC&E 5-Lead Grouped Set, Pinch (Grabber) to Multi-Link® Shielded Disposable, 50in.
• 30817357020831: AMC&E 5-lead DIN to Pinch Telemetry Leadset
• 30817357020572: AMC&E 3-lead DIN to Pinch Leadset
• 30817357020480: AMC&E 5-lead DIN to Pinch Leadset