FDA.report

MASK,FLEX,ANES,SM CHILD,SIZE 3

Primary DI
00816711022091
Brand
MASK,FLEX,ANES,SM CHILD,SIZE 3
Company
PARKER-HANNIFIN CORPORATION
Model
DMC-PEDO
Catalog number
DMC-PEDO
Device description
MASK,FLEX,ANES,SM CHILD,SIZE 3
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
BSJMask, Gas, Anesthetic

Product Code Classifications

CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816711022091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816711022091008167110220918167110220910816711022091

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

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
false

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