PITON™ Y-ADAPTOR

GUDID 20643169843077

Y-ADAPTER AC4001M PITON TJM 5PK

MEDTRONIC, INC.

Luer/Luer linear connector, single-use Luer/Luer linear connector, single-use

• Primary Device ID: 20643169843077
• NIH Device Record Key: 647935f6-0f09-4b56-b0bd-a80e2d799649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PITON™ Y-ADAPTOR
• Version Model Number: AC4001M
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store accessories in a clean, cool and dark area.
• Special Storage Condition, Specify: Between 0 and 0 *Store accessories in a clean, cool and dark area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169843073 [Primary]
GS1	20643169843077 [Package]; Contains: 00643169843073; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940063

FDA Product Code

• DTL: Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

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: 2019-10-23
• Device Publish Date: 2018-07-06

On-Brand Devices [PITON™ Y-ADAPTOR]

• 20643169002931: Y-ADAPTER AC4001M PITON TJM 5PK
• 20643169843077: Y-ADAPTER AC4001M PITON TJM 5PK