Baebies Extraction Solution 3726

GUDID 10819704020293

Baebies Extraction Solution General Purpose Reagent, For Laboratory Use

BAEBIES, INC.

Newborn metabolic screen/congenital disorder IVD, reagent

• Primary Device ID: 10819704020293
• NIH Device Record Key: 1ae8a74a-4460-486c-a688-e92e871370cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baebies Extraction Solution
• Version Model Number: 2114
• Catalog Number: 3726
• 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: 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: 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 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819704020296 [Primary]
GS1	10819704020293 [Package]; Contains: 00819704020296; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• PPM: General Purpose Reagent

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: 2019-01-14
• Device Publish Date: 2018-12-12

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