PerkinElmer 226

GUDID 50812589020011

Perkinelmer, Inc.

Blood collection paper

• Primary Device ID: 50812589020011
• NIH Device Record Key: e61bd30e-a66e-4f28-982f-cec3f8ebc33d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PerkinElmer 226
• Version Model Number: Newborn Screening Card
• Company DUNS: 968495627
• Company Name: Perkinelmer, Inc.
• Device Count: 100
• 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
GS1	00812589020016 [Unit of Use]
GS1	50812589020011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121864

FDA Product Code

• PJC: Newborn Screening Specimen Collection Paper

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: 2016-08-29

On-Brand Devices [PerkinElmer 226]

• 60812589020018: Newborn Screening Card
• 50812589020011: Newborn Screening Card
• 40812589020014: Newborn Screening Card
• 30812589020017: Newborn Screening Card
• 20812589020010: Newborn Screening Card