COOK

Basic Information

• Brand Name: COOK
• Primary DI: 00827002516076
• Version / Model: G51607
• Catalog Number: K-MAR-5200-US
• Company Name: WILLIAM A. COOK AUSTRALIA PTY. LTD.
• Labeler DUNS: 758568000
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: c8541174-3b33-4bfd-b658-695c8d1f9f16

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQG	ACCESSORY, ASSISTED REPRODUCTION	Obstetrics/Gynecology	884.6120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65203	IVF oocyte aspiration pump	An electrically-powered device, which may include noninvasive accessories, intended to generate negative pressure for aspiration of oocytes (eggs) from the ovarian follicles during the oocyte harvesting phase of an in vitro fertilization (IVF) procedure. The device may incorporate a pressure gauge/controls, and may include collection containers or tubing; it does not include patient contact devices (e.g., aspiration needle).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002516076	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160753	000
K992070	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place