Stop Solution 34-2337-11

GUDID 07333066012483

Stop Solution

Phadia AB

Plasma protein IVD, reagent

• Primary Device ID: 07333066012483
• NIH Device Record Key: 3e162544-5545-42ab-80ee-2b0220d4c89b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stop Solution
• Version Model Number: 34-2337-11
• Catalog Number: 34-2337-11
• Company DUNS: 354019424
• Company Name: Phadia AB
• 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: false
• 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

Customer Support Contacts

• Phone: +469999999999
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066012483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051218

FDA Product Code

• DHB: SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Stop Solution]

• 07333066012483: Stop Solution
• 07333066011523: Stop Solution
• 07333066000657: Stop Solution
• 07333066000459: Stop Solution