Sperm Preparation Medium

GUDID 00888937800791

Sperm Preparation Medium with phenol red. 60 ml

Origio A/S

IVF medium

• Primary Device ID: 00888937800791
• NIH Device Record Key: 73b91a31-ff54-409e-b347-4f6fbf9cfbdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sperm Preparation Medium
• Version Model Number: 10700060D
• Company DUNS: 305424269
• Company Name: Origio A/S
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937800791 [Primary]
GS1	20888937800795 [Package]; Package: 10705060D 5x60 ml [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991332

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Sperm Preparation Medium]

• 20888937829390: Sperm Preparation Medium with phenol red. 10x10 ml
• 20888937817403: Sperm Preparation Medium without phenol red. 10x10 ml
• 20888937800856: Sperm Preparation Medium. 2x10 ml
• 00888937800791: Sperm Preparation Medium with phenol red. 60 ml
• 00888937800708: Sperm Preparation Medium without phenol red. 60 ml