FDA.report

Olympus

Primary DI
14042761001707
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
A0400
Catalog number
A0400
Device description
Sealing cap, blue, for Luer-lock, 6 pcs.
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCPEndoscope, Ac-Powered And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GCPEndoscope, Ac-Powered And AccessoriesGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14042761001707PrimaryGS10
04042761001700Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1404276100170714042761001707
04042761001700040427610017004042761001700

GMDN Terms

TermDefinition
Endoscopic suction valve, reusableA non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags

DUNS number
316957240
Device count
6
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 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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