AccessGUDID - DEVICE: DEBRIDEMENT SUCKER (B0662010640000)

GUDID

Device Identifier (DI) Information

Brand Name: DEBRIDEMENT SUCKER
Version or Model: 201064-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 201064-000
Company Name: NOVOSCI CORP.

Primary DI Number: B0662010640000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a suction pump powered by compressed air or oxygen from a hospital's central gas system, tubing, plastic/glass collection container(s), a vacuum gauge, a regulator, an overflow trap, a moisture filter, and possibly a microbial filter. The pressurized gas enables the pump to create a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of hospital or other healthcare settings.

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:	Yes
Prescription Use (Rx):	Yes
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?
63649	General-purpose surgical suction system, vacuum	An assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 525cae2c-ba0f-4367-8bd6-712b796210ee
Public Version Date: June 20, 2023
Public Version Number: 4
DI Record Publish Date: October 06, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B0662010640005	100	B0662010640000	In Commercial Distribution	OUTER SHIPPER
B0662010640003	25	B0662010640000	In Commercial Distribution	INNER CARTON
B0662010640007	75	B0662010640000	In Commercial Distribution	PARTIAL CASE
B0662010640006	50	B0662010640000	In Commercial Distribution	PARTIAL CASE