Sydney IVF K-SIFM-100-AA

GUDID 00827002463059

SYDNEY IVF, FERTILIZATION MEDIUM

WILLIAM A. COOK AUSTRALIA PTY. LTD.

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: 00827002463059
• NIH Device Record Key: 23a6e29b-d4b3-43b4-a879-ccb825bee2bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sydney IVF
• Version Model Number: G46305
• Catalog Number: K-SIFM-100-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: 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

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
• 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
• 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	00827002463059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153290

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: 2016-12-15

On-Brand Devices [Sydney IVF]

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• 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