DEVICE: OLYMPUS (15019778003191)

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Device Record History
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Device Identifier (DI) Information
OLYMPUS
OFP-2 (US)
In Commercial Distribution

KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
15019778003191
GS1

1
217061423 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36023 Endoscopic irrigation/aspiration pump
A mains electricity (AC-powered) device intended to generate positive and/or negative pressures, to irrigate and/or aspirate a body cavity or lumen with sterile fluid (e.g., saline water) through an endoscope typically to facilitate observation of a site with an endoscope (e.g., during arthroscopy), and/or to keep clear the working channel of an endoscope or lumen of a catheter.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
FEQ Pump, Air, Non-Manual, For Endoscope
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: ROOM TEMPERATURE
Storage Environment Atmospheric Pressure: between -40 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
dc0181ed-cb9c-4db4-bd6a-2a655c00b50a
March 29, 2018
2
September 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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