FDA.report

Nasal Hood For Anesthesia Single Use Large Vanilla Scented

Primary DI
05055788753773
Brand
Nasal Hood For Anesthesia Single Use Large Vanilla Scented
Company
FLEXICARE MEDICAL LIMITED
Model
035-55-230VU
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
true

Related Records

Product Codes

CodeName
KHAMask, Scavenging

Product Code Classifications

CodeDeviceSpecialtyClass
KHAMask, ScavengingAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055788753773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055788753773050557887537735055788753773

GMDN Terms

TermDefinition
Anaesthesia face mask, single-useA 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 single-use device.

Sterilization Methods

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

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