FDA.reportPublic FDA data

Spiracle Technology - FERNO2 - DAN

Primary DI
00814940021564
Brand
Spiracle Technology - FERNO2 - DAN
Company
Spiracle Technology
Model
T50520
Device description
CPR Mask
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171961000Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)Xiamen Compower Medical Tech. Co., Ltd.2017-11-17CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814940021564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814940021564008149400215648149400215640814940021564

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, single-useA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use 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
00814940021519FERNO2T105652016-11-29
00814940020185FERNO2 HFOCT25301T253012016-11-09
00814940020055FERNO2T305332017-04-12
00814940020062FERNO2T305322017-04-12
00814940020079FERNO2T305312017-04-12
00814940020109FERNO2T10460192017-02-16
00814940020208FERNO2 OX InhalatorT25302-10T25302-102016-11-09
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
09341394005242AeroShield CPR MaskAERO HEALTHCARE (US), LLCKGB2026-04-21
09341394027183AeroShield CPR Face ShieldAERO HEALTHCARE (US), LLCKGB2026-04-02
10197344009602HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344009619HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011476HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011483HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011506HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011810HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344042180HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10889483570562AirLife™AIRLIFECBP2025-03-28
10889483569238AirLife™AIRLIFEKGB2025-02-19
00026072023365BFAllied Medical, LLCKGB2024-10-11
00628725095547Face mask - PediatricCanadian Hospital Specialties LimitedKGB2024-05-16
00628725096971Pediatric Non-Rebreathing Oxygen MaskCanadian Hospital Specialties LimitedKGB2024-04-22
00628725099767PEDIATRIC THREE-IN-ONE MASKCanadian Hospital Specialties LimitedKGB2024-04-04
10840330704448ProCureTwin Med, LLCKGB2024-03-22
10840330704455ProCureTwin Med, LLCKGB2024-03-22
10840330704462ProCureTwin Med, LLCKGB2024-03-22
10840330704479ProCureTwin Med, LLCKGB2024-03-22
00628725096919Adult Oxygen MaskCanadian Hospital Specialties LimitedKGB2024-02-23
00628725096926Adult Oxygen Mask High ConcentrationCanadian Hospital Specialties LimitedKGB2024-02-23
00628725096933Pediatric Non-Rebreathing Oxygen MaskCanadian Hospital Specialties LimitedKGB2024-02-23
B0023000X0RescuerB.L.S. Systems LimitedCBP2023-12-11
10850049784747SURGYCOSurgyco LLCKGB2023-10-31
10850049784754SURGYCOSurgyco LLCKGB2023-10-31
10850049784761SURGYCOSurgyco LLCKGB2023-10-31
09420012445261Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2023-07-06
00628725099798Pediatric High Concentration Oxygen MaskCanadian Hospital Specialties LimitedKGB2023-06-30