Isolaer Aerosol Isolation Barrier

GUDID 00860005664009

Patient examination/treatment drape, single-use

Primary Device ID	00860005664009
NIH Device Record Key	f05fb89b-b8a5-4a3a-9d91-e3dff05620d8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Isolaer Aerosol Isolation Barrier
Version Model Number	IB-1000
Company DUNS	117606791
Company Name	Inquis Medical, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860005664009 [Primary]

ERY	Drape, Surgical, Ent

Steralize Prior To Use	false
Device Is Sterile	false

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00860005664009 - Isolaer Aerosol Isolation Barrier	2021-02-11The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during ENT procedures.
00860005664009 - Isolaer Aerosol Isolation Barrier	2021-02-11 The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during