TRACHEAL INTUBATION FIBERSCOPE

Primary DI
04953170340192
Brand
TRACHEAL INTUBATION FIBERSCOPE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OLYMPUS LF-DP
Device description
LF-DP TRACHEAL INTUBATION FIBE RSCOPE-PO
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOQBRONCHOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981543000OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENTThe Olympus Optical Co.1998-06-08EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170340192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170340192049531703401924953170340192

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic intubation laryngoscopeAn endoscope with a flexible inserted portion intended for the visual examination of the upper airway and to assist the entry and positioning of a special airway tube [a long thin version of an endotracheal (ET) tube] to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is very long and thin to facilitate entry and the intubation procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Ethylene Oxide""]"
High-level Disinfectant;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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