MISTIC P7000

GUDID 00612223700010

NEBULIZER,BARREL REUSABLE BOTTLE 1000ML

PEGASUS RESEARCH CORPORATION

Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor Nebulizing adaptor

Primary Device ID	00612223700010
NIH Device Record Key	373e7ad1-fad7-4a51-b796-dc2eaaa9959f
Commercial Distribution Status	In Commercial Distribution
Brand Name	MISTIC
Version Model Number	P7000
Catalog Number	P7000
Company DUNS	185432994
Company Name	PEGASUS RESEARCH CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Device Dimensions

Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch
Outer Diameter	3.5 Inch
Height	9 Inch
Width	3.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612223700010 [Package] Contains: 00612223700058 Package: CS [6 Units] In Commercial Distribution
GS1	00612223700058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K893942

FDA Product Code

CAF	Nebulizer (Direct Patient Interface)