AccessGUDID - DEVICE: ATMOS (04250365135992)

GUDID

Device Identifier (DI) Information

Brand Name: ATMOS
Version or Model: C 451
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 340.0300.2
Company Name: ATMOS MedizinTechnik GmbH & Co. KG

Primary DI Number: 04250365135992
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 319591939 *Terms of Use

Device Description: Medical suction unit for suction of secretions, blood, serous fluids, rinsing fluids and temporarily collection of this fluids

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?
36777	General-purpose suction system, line-powered	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 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 can be used in a wide variety of settings within healthcare facilities.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BTA	Pump, Portable, Aspiration (Manual Or Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090445	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45996217-82e8-49f9-90ca-0f11080fea1b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 27, 2017