FDA.reportPublic FDA data

RUSCH

Primary DI
14026704625786
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN048586
Catalog number
0055530
Published
2018-09-21
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
34026704625780Direct MarkingGS10
44026704625787PackageGS112Not in Commercial Distribution
14026704625786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670462578034026704625780
4402670462578744026704625787
1402670462578614026704625786

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, reusableThe hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store devices in accordance with the facility's hygiene practice policy in a containment system that ensures clean and dry storage.

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
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

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
25056094503162PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
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