FDA.reportPublic FDA data

FERNO2 OX Inhalator

Primary DI
00814940020208
Brand
FERNO2 OX Inhalator
Company
Spiracle Technology
Model
T25302-10
Catalog number
T25302-10
Device description
OX Series Inhalator valve, demand valve used with spontaneously breathing patients
Published
2016-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963755000SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATORSpiracle Technology1997-04-08CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814940020208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814940020208008149400202088149400202080814940020208

GMDN Terms#

Term, Definition table
TermDefinition
Demand valveA non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
836002451
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814940020048FERNO2T605402017-04-12
00814940020505FERNO260541-012017-11-15
00814940021564Spiracle Technology - FERNO2 - DANT505202023-06-09
00814940021519FERNO2T105652016-11-29
00814940020185FERNO2 HFOCT25301T253012016-11-09
00814940020055FERNO2T305332017-04-12
00814940020062FERNO2T305322017-04-12
00814940020079FERNO2T305312017-04-12
00814940020109FERNO2T10460192017-02-16
00814940021410FERNO2 T305342017-04-12
00814940021427FERNO2T305352017-03-08
00814940021434FERNO2T305362017-04-12
00814940020093FERNO2T505202017-03-08
00814940020833FERNO2T50550-002017-04-12
00814940020840FERNO2T50550-012017-04-12
00814940020857FERNO2T50550-022017-04-12
00814940020864FERNO2T50550-032017-04-12
00814940020871FERNO2T50550-042017-04-12
00814940020888FERNO2T50550-052017-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946430426185GFAXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-06-01
B448260103XpectFirstar Healthcare Company Limited (Guangzhou)CBP2026-05-13
10889483570562AirLife™AIRLIFECBP2025-03-28
B0023000X0RescuerB.L.S. Systems LimitedCBP2023-12-11
09420012445261Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2023-07-06
00634376498507(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves RONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
0076658801349724M - Tampa Electric Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
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0076658811012710PC - UP - 380-54620 - LocamotiveCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812001010M - State of South Dakota DOT BBP - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812068310PW - Hawaiian TelecomCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812072018PR - First Aid Complete Kit - Poly RedCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812082916PW - PCI Construction - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588121079FAC-4 - Miller & Long ConcreteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812966275V - UP Facilities - RefillCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813049136M - PacifiCorp - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813058316PW - Los Alamos - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15