DEVICE: FUJIFILM (04547410339437)

Device Identifier (DI) Information

FUJIFILM
SB-601
In Commercial Distribution

FUJIFILM CORPORATION
04547410339437
GS1

1
713565195 *Terms of Use
This product is the suction button used in combination with our endoscopes in medical facilities.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endoscopic suction valve, reusable A 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FFY Adaptor, bulbs, miscellaneous, for endoscope
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
High-level Disinfectant
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: There must be no condensation.
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between 10 and 40 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

72b96413-4763-4b18-81ba-494ce7cf4d1e
March 29, 2018
2
September 16, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+018002728465
xxx@xxx.xxx
CLOSE