AccessGUDID - DEVICE: Medic (04719875322082)

GUDID

Device Identifier (DI) Information

Brand Name: Medic
Version or Model: M-OA-FH01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDIC TRADE CO., LTD.

Primary DI Number: 04719875322082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656820797 *Terms of Use

Device Description: The Expiratory Filter Heater is designed to warm the surface of a filter used in the expiratory pathway of a breathing circuit. The device is intended to prolong filter efficiency by minimizing excessive condensation that can cause expiratory resistance. Adding a heated filtration system to a ventilator can also protect the exhalation system and currounding environment from contamination which prevents the spread of infectious diseases. The heater consists of an aluminum heating surface that is thermostatically controlled to maintain an ideal temperature.

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?
61736	Breathing circuit condenser	A portable, mains electricity (AC-powered) device designed to be integrated within the expiratory limb of a ventilator breathing circuit to remove excess moisture through cooling and condensing, whilst also reheating the dried gases to an appropriate ventilator-compatible temperature. It includes a heat exchanger and may include disposable condensate collection devices (e.g., cartridge, collection bag). It is intended to prevent condensation from forming within the expiratory limb and ventilator (rain-out).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRQ	Unit, Heating, Powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f1e9f6b-da6e-4932-a378-67a2e24f7397
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: March 30, 2023