HemoSphere HEMRLSTD1000

GUDID 00690103197105

HemoSphere Roll Stand

Edwards Lifesciences LLC

Medical monitor/light stand Medical monitor/light stand Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered

• Primary Device ID: 00690103197105
• NIH Device Record Key: ff42f82e-ad61-48d1-b9b2-149c90b1228e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoSphere
• Version Model Number: HEMRLSTD1000
• Catalog Number: HEMRLSTD1000
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: true
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103197105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163381

FDA Product Code

• DQE: Catheter, Oximeter, Fiberoptic

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: 2019-10-23
• Device Publish Date: 2017-07-24

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