AccessGUDID - DEVICE: Pall® Oxygenator Gas Line Filter (05034480000446)

GUDID

Device Identifier (DI) Information

Brand Name: Pall® Oxygenator Gas Line Filter
Version or Model: ORO1H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ORO1H
Company Name: Pall International Sàrl

Primary DI Number: 05034480000446
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 485050483 *Terms of Use

Device Description: Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other contaminants from oxygen and other medical gases.

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":	Yes
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?
60839	Microbial medical gas filter, sterile, single-use	A sterile screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia, and/or surgical intervention (e.g., insufflation); it has no additional non-filtering intended uses. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JQC	CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

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
Device Size Text, specify: >99.999% airborne bacterial removal efficiency

Device Record Status

Public Device Record Key: 9ed37a22-2a66-41dd-85ef-5fa11917fe1e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 20, 2016