Baebies 0975

GUDID 00819704020043

Quality Control Dried Blood Spot - Low

BAEBIES, INC.

Newborn metabolic screen/congenital disorder IVD, control

• Primary Device ID: 00819704020043
• NIH Device Record Key: 2f081f06-9f42-473f-a0da-c39e5a28850d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baebies
• Version Model Number: 0975
• Catalog Number: 0975
• Company DUNS: 079264306
• Company Name: BAEBIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819704020043 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-18

On-Brand Devices [Baebies]

• 00819704020210: Quality Control Dried Blood Spot - Intermediate
• 00819704020067: Quality Control Dried Blood Spot - High
• 00819704020050: Quality Control Dried Blood Spot - Medium
• 00819704020043: Quality Control Dried Blood Spot - Low
• 00819704020036: Quality Control Dried Blood Spot - Base Pool