Thermo Fisher

GUDID 05051663002981

UNHEATED CHINA ONLY

THERMO SHANDON LIMITED

Microscope slide stainer IVD

• Primary Device ID: 05051663002981
• NIH Device Record Key: 3f01f204-c2a4-4436-b567-20be9d5eddbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Fisher
• Version Model Number: Gemini AS
• Company DUNS: 219103512
• Company Name: THERMO SHANDON LIMITED
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051663002981 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

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: 2020-09-24
• Device Publish Date: 2020-09-16

On-Brand Devices [Thermo Fisher]

• 05051663001687: 240v
• 05051663001076: 100-240V 50/60HZ WITH STARTER KIT
• 05051663002578: 220-240V 50/60HZ (CHINA ONLY)
• 05051663002561: EMBEDDING MODULE
• 05051663002448: AUTOSTAINER 360
• 05051663009249: 50/60HZ EX-DEMO
• 05051663009225: 110-240V 50/60HZ (US MAINSLEAD SET)
• 05051663009164: (EX-DEMO)
• 05051663008839: 100-240V 50/60HZ EX-DEMO
• 05051663008822: HEATED CHINA ONLY (EX-DEMO)
• 05051663008754: 100-240V 50/60HZ (CHINESE MAINSLEAD SET)
• 05051663008624: 100-240V 50/60HZ (CHINA ONLY)
• 05051663008617: 100-240V 50/60HZ
• 05051663007931: 100-240V 50/60HZ & 1ST YEAR ACCESSORY BUNDLE
• 05051663007924: 100-240V 50/60HZ (CHINA) - EX-DEMO
• 05051663007917: UNHEATED (EX-DEMO)
• 05051663007900: HEATED (EX-DEMO)
• 05051663007870: 48 SLIDE STAINER WITH PRE-TREATMENT MODULE & ACCESSORY KITS EX-DEMO
• 05051663007863: (EX-DEMO)
• 05051663007856: 100-240V 50/60HZ (SCHUKO MAINSLEAD SET)
• 05051663006170: SLIDE STAINER 230V 50HZ EX-DEMO
• 05051663006163: 100-240V 50/60HZ (EX-DEMO)
• 05051663005029: PROCESSOR 100-240V 50/60HZ
• 05051663005012: PROCESSOR 100-240V 50/60HZ
• 05051663005005: PROCESSOR 100-240V 50/60HZ
• 05051663003117: EX-DEMO 220-240V 50/60HZ
• 05051663003100: 220-240V 50/60 HZ
• 05051663003001: 100-240V 50/60Hz (CHINA ONLY)
• 05051663002998: 100-240V 50/60HZ
• 05051663002981: UNHEATED CHINA ONLY
• 05051663002974: HEATED CHINA ONLY
• 05051663002967: UNHEATED
• 05051663002950: HEATED
• 00505166300228: 220-240V 50/60 Hz
• 05051663002431: 220-240V 50/60HZ (CHINA ONLY)
• 05051663002424: 100-120V 50/60HZ
• 05051663002417: 220-240V 50/60HZ
• 05051663002301: 220-240V 50/60 Hz (CHINA ONLY)
• 05051663002295: 100-120V 50/60 Hz
• 05051663002288: HISTOSTAR
• 05051663002219: CLEARVUE EX-DEMO
• 05051663001946: AUTOSTAINER 720 & PT 110V
• 05051663001939: AUTOSTAINER 720 & PT 110V
• 05051663001922: AUTOSTAINER 720 & PT 220V
• 05051663001915: AUTOSTAINER 480S PT 110V
• 05051663001908: AUTOSTAINER 480S PT 220V
• 05051663001892: 36 SLIDE STAINER WITH PRE-TREATMENT MODULE ACCESSORY KITS & PUMP KIT
• 05051663001885: 36 SLIDE STAINER WITH PRE-TREATMENT MODULE ACCESSORY KITS & PUMP KIT
• 05051663001823: CYTOSPIN 4
• 05051663001816: 100-240V 50/60HZ (SCHUKO MAINSLEAD SET)