VitaVitro

GUDID 06971982050014

Shenzhen Vitavitro Bio-Tech Co.,Ltd

Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit Assisted reproduction vitrification kit

• Primary Device ID: 06971982050014
• NIH Device Record Key: 1e326606-aa29-4955-89d4-4c7bbe733147
• Commercial Distribution Discontinuation: 2019-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VitaVitro
• Version Model Number: LD-1.0
• Company DUNS: 544504573
• Company Name: Shenzhen Vitavitro Bio-Tech Co.,Ltd
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971982050014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180073

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-05
• Device Publish Date: 2018-12-05

On-Brand Devices [VitaVitro]

• 06971982050021: ZG-1.0
• 06971982050014: LD-1.0
• 06971982050007: Jd-1.0
• 06971982050052: 30ml
• 06971982050045: 10ml
• 06971982050038: 5ml
• 06971982050106: Gamete Buffer Medium, 60mL
• 06971982050090: Fertilization Medium, 60mL
• 06971982050083: Fertilization Medium, 30mL
• 06971982050076: Flushing Buffer Medium, 125mL
• 06971982050069: Flushing Buffer Medium, 60mL
• 06971982050199: Sperm Washing Medium, 125 mL
• 06971982050182: Sperm Washing Medium, 60 mL
• 06971982050175: Sperm Washing Medium, 30 mL
• 06971982050168: Sperm Gradient Medium SG-80, 125 mL
• 06971982050151: Sperm Gradient Medium SG-80, 30 mL
• 06971982050144: Sperm Gradient Medium SG-80, 12 mL
• 06971982050137: Sperm Gradient Medium SG-40, 125 mL
• 06971982050120: Sperm Gradient Medium SG-40, 30 mL
• 06971982050113: Sperm Gradient Medium SG-40, 12 mL
• 16971982050035: Sperm Gradient Medium, 125 mL
• 16971982050011: Sperm Gradient Medium, 30 mL
• 16971982050004: Sperm Gradient Medium, 12 mL
• 06971982050632: 10 sets/pack
• 06971982050625: Culture Dish ,Well of the Well Dish,1 set/pack
• 06971982050618: Culture Dish, 4-Well Culture Dish, 5 sets/pack
• 06971982050601: Culture Dish,4-Well Culture Dish,1 set/pack
• 06971982050595: Culture Dish ,Humdish,10 sets/pack
• 06971982050588: Culture Dish, Humdish, 1 set/pack
• 06971982050571: Culture Dish, Central Well Culture Dish, 10 sets/
• 06971982050564: The Version or Model Number i.e. "Culture Dish, Central Well Culture Dish, 1 set/pack".
• 06971982050557: Culture Dish 100mm, 10 sets/pack
• 06971982050540: Culture Dish 90 mm, 10 sets/pack
• 06971982050533: Culture Dish 60 mm,10 sets/pack
• 06971982050526: Culture Dish 35 mm,10 sets/pack