FDA.reportPublic FDA data

FERNO2

Primary DI
00814940020048
Brand
FERNO2
Company
Spiracle Technology
Model
T60540
Device description
MVP Manual Aspirator
Published
2017-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BSYCatheters, Suction, Tracheobronchial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814940020048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814940020048008149400200488149400200480814940020048

GMDN Terms#

Term, Definition table
TermDefinition
Emergency airway clearance suction system, manualA portable assembly of devices, which includes a non-surgical invasive component, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes a manually-powered (hand or foot-operated) suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
836002451
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
06925816656057Suction CatheterWell Lead Medical Co.,LtdBSY2026-06-03
10080196033553MEDLINEMEDLINE INDUSTRIES, INC.BSY2026-05-15
10850014574878Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-15
10850014574892Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-15
10850014574915Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-15
10850014574922Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-15
10850014574854Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574953Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574977Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574014Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574038Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574052Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10704411012665AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012672AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012689AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012696AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012702AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012719AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012726AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012733AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012740AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012757AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012764AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012771AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012825AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012832AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012849AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012856AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012863AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012870AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23