AccessGUDID - DEVICE: Neptune (04546540916044)

GUDID

Device Identifier (DI) Information

Brand Name: Neptune
Version or Model: 0700005000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0700-005-000
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540916044
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Docking Station with Detergent Dispenser 120 V~ 50-60Hz 3A

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48028	Surgical fluid/smoke waste management system disposal unit	A fixed-position, mains electricity (AC-powered) device designed to accept a surgical fluid/smoke waste management system's mobile suction unit for the automatic emptying and cleaning of the suction unit's collection containers after use. The disposal unit is connected to the water supply and fluid waste drain (sewage system) of the facility, and is typically placed in a utility room/disposal area.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYD	APPARATUS, EXHAUST, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ba17c89-7050-4090-9731-d8f799de62c8
Public Version Date: December 30, 2019
Public Version Number: 4
DI Record Publish Date: October 17, 2016