HEMOSPHERE HEMDPT1000

GUDID 00690103199338

DPT OUT CABLE

Edwards Lifesciences LLC

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00690103199338
• NIH Device Record Key: 97daaf68-265d-484a-ad89-f528c66c0e00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEMOSPHERE
• Version Model Number: HEMDPT1000
• Catalog Number: HEMDPT1000
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 15.2 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103199338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180881

FDA Product Code

• QAQ: Adjunctive Predictive Cardiovascular Indicator

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: 2019-07-25
• Device Publish Date: 2019-07-17

On-Brand Devices [HEMOSPHERE]

• 00690103199321: Pressure Cable
• 00690103197105: HemoSphere Roll Stand
• 00690103197006: HemoSphere Advanced Monitor
• 00690103196993: HemoSphere Swan-Ganz Module
• 00690103196986: HemoSphere Oximetry Cable
• 00690103199338: DPT OUT CABLE
• 00690103202762: CLEARSIGHT MODULE