Exp-Valve disposable

GUDID 04048675421610

Drägerwerk AG & Co. KGaA

Non-rebreathing valve, single-use Non-rebreathing valve, single-use Non-rebreathing valve, single-use Non-rebreathing valve, single-use Non-rebreathing valve, single-use Non-rebreathing valve, single-use Non-rebreathing valve, single-use Non-rebreathing valve, single-use

Primary Device ID	04048675421610
NIH Device Record Key	22a1deb7-22b3-412e-a819-c90a6f179e35
Commercial Distribution Status	In Commercial Distribution
Brand Name	Exp-Valve disposable
Version Model Number	MP01061
Company DUNS	315578914
Company Name	Drägerwerk AG & Co. KGaA
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675421610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K003068

FDA Product Code

CBK	Ventilator, Continuous, Facility Use

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-06-27
Device Publish Date	2022-06-17

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