FDA.reportPublic FDA data

Olympus

Primary DI
04042768501678
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
WB950167
Catalog number
WB950167
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
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FEQPump, Air, Non-Manual, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042768501678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042768501678040427685016784042768501678

GMDN Terms#

Term, Definition table
TermDefinition
Basic roller pumpA mains electricity (AC-powered) pump using rotating rollers which squeeze a soft-walled tubing against the housing wall, thus producing a pulsatile pumping effect. It is typically used for the delivery of precise quantities of liquids (e.g., for laboratory devices and equipment). For the roller pump used in open heart surgery see the appropriate GMDN code.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316957240
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
04042761005722OlympusA3764AA3764A2016-09-21
04042761005739OlympusA3765AA3765A2016-09-21
04042761077729OlympusWA2P400AWA2P400A2016-09-21
04042761002981OlympusA2250A22502016-09-21
04042761009805OlympusA60210AA60210A2016-09-21
04042761009812OlympusA60211AA60211A2016-09-21
04042761010214OlympusA64310AA64310A2016-09-21
04042761010283OlympusA64610AA64610A2016-09-21
04042761010290OlympusA64610LA64610L2016-09-21
04042761010306OlympusA64620AA64620A2016-09-21
04042761010351OlympusA64820LA64820L2016-09-21
04042761010436OlympusA66070AA66070A2016-09-21
04042761010610OlympusA70959AA70959A2016-09-21
04042761011068OlympusA7517A75172016-09-21
04042761011082OlympusA7519A75192016-09-21
04042761020381OlympusA20975AA20975A2016-09-21
04042761021142OlympusA22073AA22073A2016-09-21
04042761021173OlympusA22083AA22083A2016-09-21
04042761021203OlympusA22087AA22087A2016-09-21
04042761023054OlympusA37000AA37000A2016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50724995228922DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228946DEFENDOMEDIVATORS INC.FEQ2024-01-18
04065655000375ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000405ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000825ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000863ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000894ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000924ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000955ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655000986ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001013ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655001044ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001075ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001105ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
15019778005072OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFEQ2023-07-05
15019778005089OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFEQ2023-07-05
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50603468009742CS-10-00-315 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
50603468009810CS-10-30-315 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
50603468009988CS-10-00-330 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
50603468010014CS-10-30-330 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
10724995183810AquaShieldUS EndoscopyFEQ2020-04-01
10724995183827AquaShieldUS EndoscopyFEQ2020-04-01
10724995183834AquaShieldUS EndoscopyFEQ2020-04-01
10724995183841AquaShieldUS EndoscopyFEQ2020-04-01
10724995183858AquaShieldUS EndoscopyFEQ2020-04-01