AccessGUDID - DEVICE: COOK (00827002516076)

GUDID

Device Identifier (DI) Information

Brand Name: COOK
Version or Model: G51607
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K-MAR-5200-US
Company Name: WILLIAM A. COOK AUSTRALIA PTY. LTD.

Primary DI Number: 00827002516076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 758568000 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQG	ACCESSORY, ASSISTED REPRODUCTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160753	000
K992070	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dark, dry, cool place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8541174-3b33-4bfd-b658-695c8d1f9f16
Public Version Date: August 18, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016