Procedure Products Adapters 47-722

GUDID B160477221

I.V. UNIVERSAL STANDARD TUBING SPIKE

PROCEDURE PRODUCTS, INC.

Intravenous fluid bag spike

• Primary Device ID: B160477221
• NIH Device Record Key: d3068392-55e5-42ce-9bf1-72323d06fb7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Products Adapters
• Version Model Number: 47-722
• Catalog Number: 47-722
• Company DUNS: 151507563
• Company Name: PROCEDURE PRODUCTS, 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B160477221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910673

FDA Product Code

• KPE: Container, I.V.

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: 2018-02-12

On-Brand Devices [Procedure Products Adapters]

• B16080751: Adapter, Lock to Male
• B16080421: Adapter, Male lock to Male lock
• B16080351: TORQUE DEVICE,.032 TO .038
• B160477221: I.V. UNIVERSAL STANDARD TUBING SPIKE