Single Use Nasal Biliary Drainage Tube V

Primary DI
04953170309458
Brand
Single Use Nasal Biliary Drainage Tube V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
PBD-V812W-06
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944912000OLYMPUS NBD TUBESOlympus America, Inc.1995-06-13FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170309455PackageGS11Not in Commercial Distribution
04953170309458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317030945514953170309455
04953170309458049531703094584953170309458

GMDN Terms#

Term, Definition table
TermDefinition
Nasal biliary/pancreatic drainage catheterA sterile, flexible tube intended to be introduced endoscopically for the temporary drainage of the biliary and/or pancreatic duct. It is intended to navigate to the biliary and/or pancreatic tract via the sphincter of Oddi, and terminate proximally via the nasal passage; devices associated with catheter introduction/connection (excluding the endoscope) may be included (e.g., nasal transfer tube, drainage connecting tube, guidewire), however it does not include any fluid collection bags/containers. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15711055003237M-DrainMermaid Medical A/SFGE2026-09-04
15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002448Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002455Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002462Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002479Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002486Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002493Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002509Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002516Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002523Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002530Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002547Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002554Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002561Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002578Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002585Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002592Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002608Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002615Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002622Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002639Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002646Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002653Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002660Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002677Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002684Endoflux™Medi-Globe GmbHFGE2026-08-27