FDA.reportPublic FDA data

RUSCH

Primary DI
14026704613967
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN048445
Catalog number
5713D
Device description
EQUIP SET: Dolphin HANDLE + MAC 2,3,4
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704612001Direct MarkingGS10
34026704613961PackageGS120In Commercial Distribution
14026704613967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670461200134026704612001
3402670461396134026704613961
1402670461396714026704613967

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, reusableThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971355350147BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350154BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350161BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350178BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
25056094503100PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503117PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503124PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503131PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503148PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503155PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
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25056094503179PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503186PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503193PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503209PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503216PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503223PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503230PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503254PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503261PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31