AccessGUDID - DEVICE: ABS Blower Unit (00869284000249)

GUDID

Device Identifier (DI) Information

Brand Name: ABS Blower Unit
Version or Model: Model 2002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ABS-2002
Company Name: NIMBIC SYSTEMS, INC.

Primary DI Number: 00869284000249
Issuing Agency: GS1
Commercial Distribution End Date: November 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 868730834 *Terms of Use

Device Description: No description.

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):	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?
18113	High-efficiency filter air cleaner, mobile	A mains electricity (AC-powered) device that uses a combination of a prefilter and a high-efficiency particulate air (HEPA) filter to remove 99.97% of particles greater than 0.3 microns. This device is frequently used to prevent the transmission of tuberculosis (TB) and other diseases caused by airborne pathogens. It is designed to be moved from one location to another.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORC	Air Filter Portable Apparatus

FDA Premarket Submission

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

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: dad9b67b-6ec1-41d4-bcaa-0323cc57ac30
Public Version Date: February 24, 2022
Public Version Number: 2
DI Record Publish Date: November 15, 2018