AccessGUDID - DEVICE: Curaplex (00810071636448)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 1004SPCOF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 301-1004SPCOF
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00810071636448
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: TRANSPORT VENTILATOR CIRCUIT,BACTERIAL/VIRAL FILTER,9 FT EXPANDABLE CORRAGATED TUBING

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
60837	Microbial medical gas filter, single-use	A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). 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: 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: 973ea862-67cf-444e-a976-1f847ba7ccea
Public Version Date: January 09, 2023
Public Version Number: 1
DI Record Publish Date: December 30, 2022