Development Solution 34-2246-13

GUDID 07333066000442

Development Solution

Phadia AB

Plasma protein IVD, reagent

• Primary Device ID: 07333066000442
• NIH Device Record Key: ad06eef0-6599-4420-b62e-f5585ee9c53d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Development Solution
• Version Model Number: 34-2246-13
• Catalog Number: 34-2246-13
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze!

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333066000442 [Package]; Contains: 07333066019697; Package: [6 Units]; In Commercial Distribution
GS1	07333066019697 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-05
• Device Publish Date: 2019-03-28

On-Brand Devices [Development Solution]

• 07333066011097: Development Solution
• 07333066000176: Development Solution
• 07333066000640: Development Solution
• 07333066000442: Development Solution
• 07333066000435: Development Solution