PG-1000

GUDID 00815849023406

Puregraft Smart Tubing

CUSTOM ASSEMBLIES, INC.

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• Primary Device ID: 00815849023406
• NIH Device Record Key: b0854b51-824c-4fc3-b62f-cf1142a8d6c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PG-1000
• Version Model Number: PG-1000
• Company DUNS: 948904735
• Company Name: CUSTOM ASSEMBLIES, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815849023406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993463

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-21
• Device Publish Date: 2023-09-13

Devices Manufactured by CUSTOM ASSEMBLIES, INC.

• 00815849024021 - Custom Medical Specialties, Inc.: 2023-09-22 Procedure Kit
• 00815849024571 - Custom Medical Specialties, Inc.: 2023-09-22 Procedure Kit
• 00815849023369 - Custom Medical Specialties, Inc.: 2023-09-21 8’ Extension Set with Check Valve
• 00815849023390 - Custom Medical Specialties, Inc.: 2023-09-21 144" Transition Tubing
• 00815849023406 - PG-1000: 2023-09-21Puregraft Smart Tubing
• 00815849023406 - PG-1000: 2023-09-21 Puregraft Smart Tubing
• 00815849023437 - Custom Assemblies, Inc.: 2023-09-21 Procedure Kit
• 00815849023444 - Custom Assemblies, Inc.: 2023-09-21 Procedure Kit
• 00815849023451 - Custom Medical Specialties, Inc.: 2023-09-21 Procedure Kit