AccessGUDID - DEVICE: WomanCare Global Single-Valve Aspirator (00853615006277)

GUDID

Device Identifier (DI) Information

Brand Name: WomanCare Global Single-Valve Aspirator
Version or Model: SVS-LF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOMANCARE GLOBAL TRADING, INC.

Primary DI Number: 00853615006277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064730456 *Terms of Use

Device Description: The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe barrel, plunger, collar stop, and removable valve liner. Aspirators are compatible with cannulae size 3-6mm. Aspirators are clean, not sterile, and reusable.

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?
33577	Abortion suction system collection bottle	A component of an abortion (uterine) suction system designed to function as a trap to collect the products of conception from the uterus [the termination of early pregnancies (up to 12 weeks), the treatment of incomplete spontaneous abortions, the removal of retained afterbirth, menstrual regulation, or biopsy]. It is typically cylindrical in shape and connected to a wide bore tubing through which the removed material is suctioned. It may have an integrated filter made of woven textile that acts as a sieve and trap (blood passes through whilst solids are retained). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HHI	System, Abortion, Vacuum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant
Liquid Chemical

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 60 Milliliter
Outer Diameter: 3.5 Inch
Length: 8.5 Inch

Device Record Status

Public Device Record Key: 908797a6-eb00-4891-8a31-a2a489a6c6e5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016