FDA.reportPublic FDA data

Nasal Hood For Anesthesia Reusable Small

Primary DI
05055788753995
Brand
Nasal Hood For Anesthesia Reusable Small
Company
FLEXICARE MEDICAL LIMITED
Model
035-55-110U
Published
2020-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KHAMask, Scavenging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHAMask, ScavengingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055788753995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788753995050557887539955055788753995

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, reusableA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
504406273
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055788776246ProVu Video Stylet038-995-065U038-995-065U2025-05-30
05055788776260ProVu Video Stylet038-995-070U038-995-070U2025-05-30
05055788776284ProVu Video Stylet038-995-075U038-995-075U2025-05-30
05055788776307ProVu Video Stylet038-995-080U038-995-080U2025-05-30
05055788721499Flexicare040-836U2024-11-21
05055788721550Flexicare040-835U2024-11-21
05055788721802Flexicare040-831U2024-11-21
15055788722462BriteBlade Pro Evo Single-Use Fiber Optic Miller 4040-764U2024-08-07
15055788722486BriteBlade Pro Evo Single-Use Fiber Optic Miller 3040-763U2024-08-07
15055788722509BriteBlade Pro Evo Single-Use Fiber Optic Miller 2040-762U2024-08-07
15055788722523BriteBlade Pro Evo Single-Use Fiber Optic Miller 1040-761U2024-08-07
15055788722561BriteBlade Pro Evo Single-Use Fiber Optic Mac 4040-754U2024-08-07
15055788722585BriteBlade Pro Evo Single-Use Fiber Optic Mac 2040-753U2024-08-07
15055788722608BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-752U2024-08-07
15055788722622BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-751U2024-08-07
05055931127888Flexicare032-10-180LU2024-07-17
05055931127895Flexicare032-10-181LU2024-07-17
05055931127901Flexicare032-10-182LU2024-07-17
05055931127918Flexicare010-762LU2024-07-17
05055931104162ProVu040-08-0420U2024-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816711024972MATRX SCAV(WO/HOOD)WO/SHUTOFFPARKER-HANNIFIN CORPORATIONKHA2026-02-23
00810339030322SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339031138SAFE DENTBGSS Company Inc.KHA2024-05-15
00813830027464Axess CapnographyAdaptersACCUTRON, INC.KHA2023-09-22
D974BSIBL012BritedentBright Supply, Inc.KHA2023-09-18
D974BSIBL022BritedentBright Supply, Inc.KHA2023-09-18
D1243I50NE0SolidexCreo Dent Hudson Valley, Inc.KHA2023-06-07
D1243I50TC0SolidexCreo Dent Hudson Valley, Inc.KHA2023-06-07
04260635790448AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790479AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790486AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790530AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790554AirTechiquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790578AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790585AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790592AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790608AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
06933192201112Hakuna MatataFUJIAN BBC INCKHA2022-12-07
00816711020769Matrx Scavenger Large Nasal InhalerPARKER-HANNIFIN CORPORATIONKHA2022-12-06
04260635790103AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790158AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790493AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790714AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
00816711020974HOOD ASSY,ADULT,ONE LINERPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711020981HOOD ASSY,PEDO,ONE LINERPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711020998DISPOSABLE LINER, ADULT, BAGPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711021001DISP LINER,ADULT,BAG,CITRUSPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711021018DISPOSABLE LINER, ADULT, BOXPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711021025DISP LINER,ADULT,BOX,CITRUSPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711021032DISPOSABLE LINER, PEDO, BAGPARKER-HANNIFIN CORPORATIONKHA2022-11-15