Plasma Exchange tubeset 064I

GUDID 10868465000105

ASAHI KASEI MEDICAL AMERICA INC.

Apheresis system tubing set

• Primary Device ID: 10868465000105
• NIH Device Record Key: 02305dd7-55b0-4ac0-9d1c-6f4b2e9ac8f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasma Exchange tubeset
• Version Model Number: 064I
• Catalog Number: 064I
• Company DUNS: 828593785
• Company Name: ASAHI KASEI MEDICAL AMERICA 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 901-362-6105
• Email: customerservice@akmamerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868465000108 [Primary]
GS1	10868465000105 [Package]; Contains: 00868465000108; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831747

FDA Product Code

• FJK: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-23

On-Brand Devices [Plasma Exchange tubeset]

• 10868465000112: 066I
• 10868465000105: 064I