FDA.reportPublic FDA data

RUSCH

Primary DI
04026704540174
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN040303
Catalog number
004453300
Published
2018-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
34026704540175Direct MarkingGS10
24026704540178PackageGS140Not in Commercial Distribution
04026704540174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3402670454017534026704540175
2402670454017824026704540178
04026704540174040267045401744026704540174

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
Hydrogen Peroxide

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31
05060112310621LMA AIRWAY MANAGEMENTIPN9018661500252026-07-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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25056094503223PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
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04053755213115MEDUVISION Mac 2 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213122MEDUVISION Mac 4 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
00842209139149NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139156NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22