FDA.reportPublic FDA data

RUSCH

Primary DI
24026704017830
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN042563
Catalog number
154300-000030
Device description
Face mask for anesthesia, pediatric
Published
2018-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
44026704017834PackageGS1100In Commercial Distribution
24026704017830PrimaryGS10
04026704017836Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4402670401783444026704017834
2402670401783024026704017830
04026704017836040267040178364026704017836

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
2
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860015046007XChangePneuma Therapeutics, Inc.BSJ2026-10-16
00840118623681Endure IndustriesENDURE INDUSTRIESBSJ2026-08-14
06946430427496CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427519CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427533CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427557CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427571CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427595CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427618CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
14026704665010HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665188HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665218HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665225HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665232HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665249HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665256HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665263HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665270HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665041RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665065RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665072RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665089RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665096RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
10192253072037CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072044CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072051CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072068CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072075CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072082CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072105CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29