FERNO2 HFOC T25301

GUDID 00814940020185

HFOC valve, refill valve for use with Bag Valve Mask resuscitator.

Spiracle Technology

Respiratory oxygen therapy system Respiratory oxygen therapy system
Primary Device ID00814940020185
NIH Device Record Key0e474fa1-e53f-4162-8d54-e42707c53c8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFERNO2 HFOC
Version Model NumberT25301
Catalog NumberT25301
Company DUNS836002451
Company NameSpiracle Technology
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814940020185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBPValve, Non-Rebreathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-12
Device Publish Date2016-11-09

Devices Manufactured by Spiracle Technology

00814940021564 - Spiracle Technology - FERNO2 - DAN2023-06-19 CPR Mask
00814940020185 - FERNO2 HFOC2019-07-12HFOC valve, refill valve for use with Bag Valve Mask resuscitator.
00814940020185 - FERNO2 HFOC2019-07-12 HFOC valve, refill valve for use with Bag Valve Mask resuscitator.
00814940020048 - FERNO22018-08-23 MVP Manual Aspirator
00814940020505 - FERNO22018-08-23 Collection Bottle With Large Bore Catheter
00814940020055 - FERNO22018-07-06 BVM, Adult, Single Patient Use
00814940020062 - FERNO22018-07-06 BVM, Child, Single Patient Use
00814940020079 - FERNO22018-07-06 BVM, Infant, Single Patient Use
00814940020109 - FERNO22018-07-06 Wall-Mounted Blood Pressure Cuff

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