Anivia SG1000 Pump Console SG1000-PDM-004

GUDID 00850000067097

Pump Driver Module

APMTD, Inc.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00850000067097
• NIH Device Record Key: 93f90ad4-a323-4590-9b9e-06ad2bfd08b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anivia SG1000 Pump Console
• Version Model Number: SG1000-PDM-004
• Catalog Number: SG1000-PDM-004
• Company DUNS: 117004252
• Company Name: APMTD, 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: 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: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.com
• Phone: 7816462900
• Email: support_anivia@aniviamed.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 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 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 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 Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000067097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230698

FDA Product Code

• DWA: Control, Pump Speed, Cardiopulmonary Bypass

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: 2024-09-19
• Device Publish Date: 2024-09-11

On-Brand Devices [Anivia SG1000 Pump Console]

• 00850000067134: Level Sensor Module
• 00850000067127: Cart
• 00850000067110: Flow Bubble Sensor
• 00850000067103: Flow Bubble Sensor
• 00850000067097: Pump Driver Module
• 00850000067080: Pump Driver Module
• 00850000067073: Pump Driver Module
• 00850000067066: Pump Driver Module
• 00850000067059: Display and Control Module