FDA.reportPublic FDA data

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
Single use
true

Product Codes#

Code, Name table
CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816711022091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816711022091008167110220918167110220910816711022091

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
004175550
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816711024972MATRX SCAV(WO/HOOD)WO/SHUTOFF91515197915151972026-02-23
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM40151601 KOR2025-09-24
00816711020424NITRONOX SCAVENGERNOX-53002025-09-24
00816711024958PORTER,MED BR CIR,6FT,20PCKDMC-12-6DMC-12-62025-09-17
00816711024965PORTER,MED BR CIR,10FT,20PCKDMC-12-10DMC-12-102025-09-17
00816711024941HOSE N2O DISS/DISS 8 FT850885082025-02-27
00816711024224SCAVENGER, EAVS, MIDASEAVS-5000EAVS-50002025-02-21
00816711024927DEMAND VALVE, POS PR., DISS1506-1D1506-1D2025-02-21
00816711024934HA,O2,INTL (DISSF X DISSF)2FT92305297-2 92305297-2 2025-02-21
00816711024439DIGITAL MDM ASSY-120V(STAND MT40151602 915251152024-04-05
00816711023821Digital MDM, 30% Std ISO40151602 915251762023-09-05
00816711023838DIGITAL MDM 30% GERMANY91525178915251782023-09-05
00816711023845INTL DMDM (STAND)-SPAIN91525179915251792023-09-05
00816711023852INTL DMDM 40% STAND-SWEDEN91525180915251802023-09-05
00816711023869INTL DMDM (STAND)-ISRAEL91525182915251822023-09-05
00816711023876INTL DMDM,STANDARD-AUSTRALIA91525184915251842023-09-05
00816711023883INTL DMDM (STAND)-DUTCH91525185915251852023-09-05
00816711023890INTL DMDM (STAND)-CANADA91525186915251862023-09-05
00816711023906INTL DMDM,CABINET MOUNT91525187915251872023-09-05
00816711023913INTL DMDM 30%(STAND)-ITALY91525262915252622023-09-05

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Primary DI, Brand, Company table
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