DEWIN

GUDID 06972962312436

Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing and handling sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures.

DonneVie Medical Technology(Shanghai)Co.Ltd

IVF medium

• Primary Device ID: 06972962312436
• NIH Device Record Key: bc83c264-fde8-4a6e-ad8f-e98946229dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEWIN
• Version Model Number: 9340
• Company DUNS: 554479334
• Company Name: DonneVie Medical Technology(Shanghai)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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972962312436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212426

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-18
• Device Publish Date: 2022-07-08

On-Brand Devices [DEWIN]

• 36972962310150: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962310037: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 06972962312443: Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and c
• 06972962312467: (Dewin Fertilization Medium [without HSA],50mL.
• 06972962312450: Dewin Fertilization Medium without HSA. 25mL.
• 06972962312436: Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and c
• 06972962312184: Dewin Cleavage Medium [ without HSA], 50mL.
• 06972962312177: Dewin Cleavage Medium [ without HSA],25mL.
• 06972962312160: Dewin Cleavage Medium [ without HSA], 50mL.
• 06972962312153: Dewin Cleavage Medium[ with HSA ],25mL.
• 36972962310389: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962310372: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962310273: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962310433: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962310426: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962311966: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962311799: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962311638: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962311379: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962311355: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962310938: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 16972962310729: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962310716: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 36972962310174: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr
• 16972962310040: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitr