AccessGUDID - DEVICE: OCEAN (00650862100068)

GUDID

Device Identifier (DI) Information

Brand Name: OCEAN
Version or Model: 2002-070
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Atrium Medical Corporation

Primary DI Number: 00650862100068
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 051798999 *Terms of Use

Device Description: DRAIN, SINGLE - STERILE FLUID

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?
36787	Thoracic suction system	An assembly of devices designed to evacuate large volumes of fluid and/or air accumulated between the lung and chest wall (pleural space) by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system is usually employed following thoracic surgery, traumatic chest wounds, barotrauma, or pleural effusions. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	BOTTLE, COLLECTION, VACUUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043582	000

Device Exempt from Premarket Submission: No 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: ca9c32d3-ec4f-4a28-970f-6e555e7b45c9
Public Version Date: October 15, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2015