AccessGUDID - DEVICE: Isolaer Aerosol Isolation Barrier (00860005664009)

GUDID

Device Identifier (DI) Information

Brand Name: Isolaer Aerosol Isolation Barrier
Version or Model: IB-1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Inquis Medical, Inc.

Primary DI Number: 00860005664009
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 117606791 *Terms of Use

Device Description: The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during ENT procedures.

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?
61048	Patient examination/treatment drape, single-use	A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERY	Drape, Surgical, Ent

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: 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: f05fb89b-b8a5-4a3a-9d91-e3dff05620d8
Public Version Date: November 30, 2022
Public Version Number: 2
DI Record Publish Date: February 03, 2021