Sydney IVF K-SIBF-5000-AA

GUDID 00827002462946

SYDNEY IVF, BLASTOCYST CRYOPRESERVATION KIT

WILLIAM A. COOK AUSTRALIA PTY. LTD.

IVF medium kit

• Primary Device ID: 00827002462946
• NIH Device Record Key: 31085cd4-74ae-4857-bc64-28b2c9a80af2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sydney IVF
• Version Model Number: G46294
• Catalog Number: K-SIBF-5000-AA
• Company DUNS: 758568000
• Company Name: WILLIAM A. COOK AUSTRALIA PTY. 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: true
• 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

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002462946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152717

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: 2016-12-14

On-Brand Devices [Sydney IVF]

• 00827002463202: SYDNEY IVF, GAMETE BUFFER
• 00827002463189: SYDNEY IVF, GAMETE BUFFER
• 00827002463172: SYDNEY IVF, GAMETE BUFFER
• 00827002463165: SYDNEY IVF, SPERM MEDIUM
• 00827002463158: SYDNEY IVF, SPERM MEDIUM
• 00827002463141: SYDNEY IVF, SPERM MEDIUM
• 00827002463134: SYDNEY IVF, SPERM GRADIENT KIT
• 00827002463127: SYDNEY IVF, SPERM GRADIENT KIT
• 00827002463110: SYDNEY IVF, SPERMIENT
• 00827002463103: SYDNEY IVF, SPERMIENT
• 00827002463097: SYDNEY IVF, SPERM CRYOPRESERVATION BUFFER
• 00827002463080: SYDNEY IVF, FOLLICLE FLUSH BUFFER
• 00827002463073: SYDNEY IVF, FERTILIZATION MEDIUM
• 00827002463066: SYDNEY IVF, FERTILIZATION MEDIUM
• 00827002463059: SYDNEY IVF, FERTILIZATION MEDIUM
• 00827002463042: SYDNEY IVF, HYALURONIDASE
• 00827002463035: SYDNEY IVF, PVP
• 00827002463028: SYDNEY IVF, CLEAVAGE MEDIUM
• 00827002463011: SYDNEY IVF, CLEAVAGE MEDIUM
• 00827002463004: SYDNEY IVF, CLEAVAGE MEDIUM
• 00827002462991: SYDNEY IVF, EMBRYO BIOPSY MEDIUM
• 00827002462984: SYDNEY IVF, CRYOPRESERVATION KIT
• 00827002462977: SYDNEY IVF, THAWING KIT
• 00827002462960: SYDNEY IVF, BLASTOCYST MEDIUM
• 00827002462953: SYDNEY IVF, BLASTOCYST MEDIUM
• 00827002462946: SYDNEY IVF, BLASTOCYST CRYOPRESERVATION KIT
• 00827002462939: SYDNEY IVF, BLASTOCYST THAWING KIT
• 00827002462922: SYDNEY IVF, BLASTOCYST VITRIFICATION KIT
• 00827002462915: SYDNEY IVF, BLASTOCYST WARMING KIT