SEEKER™ 3141

GUDID 00819704020029

SEEKER™ disposable Cartridge

BAEBIES, INC.

Newborn metabolic screen/congenital disorder IVD, reagent

• Primary Device ID: 00819704020029
• NIH Device Record Key: 8fc19acf-c2ad-4a8a-8c5d-8a2f7f963e03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEEKER™
• Version Model Number: 1305
• Catalog Number: 3141
• Company DUNS: 079264306
• Company Name: BAEBIES, INC.
• 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: 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 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819704020029 [Primary]
GS1	10819704020026 [Package]; Package: Inner Pack [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150035

FDA Product Code

• PPM: General Purpose Reagent

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: 2017-09-19

On-Brand Devices [SEEKER™]

• 00819704020258: SEEKER™ Personal Computer
• 00819704020241: SEEKER™ Personal Computer
• 00819704020234: SEEKER™ Personal Computer
• 00819704020227: SEEKER™ Quality Control Dried Blood Spot Kit Contains 5 levels: QC Base Pool, QC Low, QC Inter
• 00819704020203: SEEKER™ Instrument & Accessories The SEEKER™ Instrument is a quantitative in vitro diagnosti
• 00819704020197: The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination
• 00819704020180: SEEKER™ LSD Reagent Kit - IDUA GAA
• 00819704020173: The SEEKER™ LSD Reagent Kit - IDUA|GAA|GBA|GLA is intended for quantitative measurement of the
• 00819704020166: SEEKER™ Stop Buffer
• 00819704020159: SEEKER™ Calibrant D
• 00819704020142: SEEKER™ Calibrant C
• 00819704020135: SEEKER™ Calibrant B
• 00819704020128: SEEKER™ Calibrant A
• 00819704020111: SEEKER™ GLA Reagent (alpha-D-galactosidase)
• 00819704020104: SEEKER™ GBA Reagent (ß-Glucocerebrosidase)
• 00819704020098: SEEKER™ IDUA Reagent (alpha-L-iduronidase)
• 00819704020081: SEEKER™ GAA Reagent (alpha-D-glucosidase)
• 00819704020029: SEEKER™ disposable Cartridge
• 00819704020012: SEEKER™ Extraction Buffer
• 00819704020005: SEEKER™ Filler Fluid