AccessGUDID - DEVICE: RespVent™ (00850108006035)

GUDID

Device Identifier (DI) Information

Brand Name: RespVent™
Version or Model: RTG-01002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RTG-01002
Company Name: CUTTING EDGE HC BRANDS LLC

Primary DI Number: 00850108006035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080216804 *Terms of Use

Device Description: RespVent HMEF 1000 Heat Moisture Exchanger with Intergrated Bacterial/Viral Filter. The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

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":	Yes
For Single-Use:	Yes
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?
46816	Heat/moisture exchanger/microbial medical gas filter	A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAH	Filter, Bacterial, Breathing-Circuit

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
Special Storage Condition, Specify: Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.

Clinically Relevant Size

[?]

Size Type Text
Weight: 24 Gram
Device Size Text, specify: Connections: 22M/15F - 22F/15M

Device Record Status

Public Device Record Key: 9745d055-900e-4a82-9769-492b271974d9
Public Version Date: February 05, 2024
Public Version Number: 7
DI Record Publish Date: October 16, 2017