ICSI Cumulase

GUDID 20888937817984

ICSI Cumulase. 5x0.5 ml

Origio A/S

IVF medium IVF medium

• Primary Device ID: 20888937817984
• NIH Device Record Key: f2a79f03-48f5-4703-a465-8a8ad5fb96ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICSI Cumulase
• Version Model Number: 16125000D
• Company DUNS: 305424269
• Company Name: Origio A/S
• Device Count: 5
• 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: 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

• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937817980 [Unit of Use]
GS1	20888937817984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081639

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: 2016-07-22

Devices Manufactured by Origio A/S

• 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