Portex/Pain Management

GUDID 30351688082262

SMITHS MEDICAL ASD, INC.

Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated

• Primary Device ID: 30351688082262
• NIH Device Record Key: 75a7854d-0b60-4eaa-af54-50817b79458a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portex/Pain Management
• Version Model Number: PDX2854
• Company DUNS: 137835299
• Company Name: SMITHS MEDICAL ASD, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	30351688082262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K965017

FDA Product Code

• CAZ: Anesthesia conduction kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-18

On-Brand Devices [Portex/Pain Management]

• 30351688082620: PDX2903
• 30351688082262: PDX2854