Procedure Products Syringe

GUDID B1604410Y322

5cc Standard Lock Syringe, Yellow Plunger, Heparin Label

PROCEDURE PRODUCTS, INC.

General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: B1604410Y322
• NIH Device Record Key: 5f9b2da8-a905-402e-94d6-9c0dad0055bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Products Syringe
• Version Model Number: 4410-Y32
• 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	B1604410Y321 [Primary]
HIBCC	B1604410Y322 [Package]; Contains: B1604410Y321; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884985

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2017-09-12

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• B1604930Y211: 10CC L.L. YELLOW SYRINGE W/ CONTRAST LABEL
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• B1604930R431: Standard 10cc Lock syrigne, Red Plunger, Lidocaine label
• B1604930R1: 10cc Standard Lock Syringe, Red Plunger
• B1604930G542: 10CC L.L. GREEN SYRINGE W/ NITRO LABEL
• B1604930G1: Standard 10cc Lock Syringe, green plunger
• B1604930B431: Standard 10cc lock syringe, Blue Plunger, Lidocaine label
• B1604410Y322: 5cc Standard Lock Syringe, Yellow Plunger, Heparin Label
• B1604410W2: 5CC LOCK STANDARD SYRINGE, WHITE
• B1604410G1: 5cc Lock Standard Syringe, Green Plunger
• B1605320Y1: 10CC PALM PAD CONTROL SYRINGE, Yellow Plunger