SAGE Vitrification Warming Kit XL

GUDID 60888937027138

SAGE Vitrification Warming Kit , ART-8034 (in plastic cryo vials): 8x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution. 2x2 ml of 0,5 M ART-8031-B Sucrose Warming Solution. 2x2 ml of ART-8031-C MOPS Solution.

Origio A/S

IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit

• Primary Device ID: 60888937027138
• NIH Device Record Key: 238edfeb-3955-4656-9215-8b9f6d508fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAGE Vitrification Warming Kit XL
• Version Model Number: ART-8034
• 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: true
• Device Combination Product: false
• Single Use: true
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	60888937027138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170560

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: 2022-12-01
• Device Publish Date: 2022-11-23

Devices Manufactured by Origio A/S

• 60888937027138 - SAGE Vitrification Warming Kit XL: 2022-12-01SAGE Vitrification Warming Kit , ART-8034 (in plastic cryo vials): 8x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution. 2x2 ml of 0,5 M ART-8031-B Sucrose Warming Solution. 2x2 ml of ART-8031-C MOPS Solution.
• 60888937027138 - SAGE Vitrification Warming Kit XL: 2022-12-01 SAGE Vitrification Warming Kit , ART-8034 (in plastic cryo vials): 8x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution. 2x2 ml o
• 00888937833027 - SynVitro Hyadase: 2021-01-26 SynVitro Hyadase. 5x1 ml
• 00888937819342 - CSC Freezing Medium: 2019-09-12 CSC Freezing Medium - Choline Substituted Cryopreservation Freezing Medium. 10 ml
• 00888937801491 - EmbryoAssist: 2019-08-29 EmbryoAssist. 10 ml
• 00888937833058 - SAGE 1-Step: 2019-03-11 Sage 1-Step GM-CSF with HSA. 3 ml
• 00888937833072 - SAGE 1-Step: 2019-03-11 SAGE 1-Step GM-CSF with SPS. 3 ml.
• 20888937972348 - Transem Spherical: 2019-01-23 Embryo transfer catheter, spherical tip.
• 20888937972355 - EchoGen Spherical: 2019-01-23 Embryo transfer catheter, echogenic/spherical. 24 cm