Allied Healthcare Products, Inc. D81

GUDID 00260720000180

Ventilator, Omni-Vent, D-8 MRI compatible control unit.

ALLIED HEALTHCARE PRODUCTS, INC.

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID00260720000180
NIH Device Record Key0cbe04de-cfb6-4029-95b0-5d4219b60f83
Commercial Distribution StatusIn Commercial Distribution
Brand NameAllied Healthcare Products, Inc.
Version Model Number0V000001
Catalog NumberD81
Company DUNS099674145
Company NameALLIED HEALTHCARE PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100260720000180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-20

On-Brand Devices [Allied Healthcare Products, Inc.]

00260720000616Portable Assy.
00260720000548Demand Valve.
00260720000500Demand Valve Japan.
00260720000180Ventilator, Omni-Vent, D-8 MRI compatible control unit.
00260720000074Transport ventilator with internal compressor.
00026072000618Portable Assy.
00026072000540Demand Valve.
00026072000502Demand Valve Japan.
00026072000182Ventilator, Omni-Vent, D-8 MRI compatible control unit.
00026072000076Transport ventilator with internal compressor.

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