AccessGUDID - DEVICE: Flying-V cuff SMALL (09120073931887)

GUDID

Device Identifier (DI) Information

Brand Name: Flying-V cuff SMALL
Version or Model: G2.1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FVMA0051
Company Name: CNSystems Medizintechnik GmbH

Primary DI Number: 09120073931887
Issuing Agency: GS1
Commercial Distribution End Date: April 10, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 300526077 *Terms of Use

Device Description: Unit; Fingersensor for Task Force® Monitor (small); Luer

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?
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSB	Plethysmograph, Impedance

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K014063	000

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 Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5dededbe-3fad-4a47-9cb1-2cefeec98279
Public Version Date: November 10, 2021
Public Version Number: 7
DI Record Publish Date: November 28, 2018