FDA.report

REPL MEDIUM NASAL HOOD

Primary DI
00816711021209
Brand
REPL MEDIUM NASAL HOOD
Company
PARKER-HANNIFIN CORPORATION
Model
91515095
Catalog number
91515095
Device description
REPL MEDIUM NASAL HOOD
Published
2022-11-15
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
00816711021209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816711021209008167110212098167110212090816711021209

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
004175550
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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