VitaVitro

GUDID 06971982050014

Shenzhen Vitavitro Bio-Tech Co.,Ltd

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
• 06971982051073: ET-IH
• 06971982051066: ET-I
• 06971982050342: ET-SI
• 06971982050335: ET-S
• 06971982050328: ET-A
• 06971982050311: ORND-17G
• 06971982050304: ORNS-18G
• 06971982050298: ORNS-17G