SEEKER™ 3145

GUDID 00819704020241

SEEKER™ Personal Computer

BAEBIES, INC.

Multichannel clinical chemistry analyser IVD, laboratory, semi-automated Multichannel clinical chemistry analyser IVD, laboratory, semi-automated Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory Multichannel clinical chemistry analyser IVD, laboratory

• Primary Device ID: 00819704020241
• NIH Device Record Key: 0234fab4-5505-4040-b9fd-8dba7cbf1a1d
• Commercial Distribution Discontinuation: 2017-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SEEKER™
• Version Model Number: 3145
• Catalog Number: 3145
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com
• Phone: (844) 244-4034
• Email: techsupport@baebies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819704020241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150035

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

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: 2017-08-04

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