AccessGUDID - DEVICE: LoFlo Sidestream Consumables (00847946024017)

GUDID

Device Identifier (DI) Information

Brand Name: LoFlo Sidestream Consumables
Version or Model: 9355-0277
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Medical Corporation

Primary DI Number: 00847946024017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: KIT, ADAPTER, AIRWAY, W/DEHUMID TUBING, ADULT/PEDIATRIC, BOX OF 10, (REF: 3573ADU-00)

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):	No
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?
45566	Gas-sampling/monitoring respiratory tubing, single-use	A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated external defibrillators (non-wearable)

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
Handling Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 261391e3-5f0e-4066-980b-c3224cb7f4d0
Public Version Date: August 05, 2022
Public Version Number: 2
DI Record Publish Date: June 17, 2021