AccessGUDID - DEVICE: SMARTCAN™ LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGE (05030267162291)

GUDID

Device Identifier (DI) Information

Brand Name: SMARTCAN™ LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGE
Version or Model: 2169003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intersurgical Incorporated

Primary DI Number: 05030267162291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785952607 *Terms of Use

Device Description: SMARTCAN™ LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGE

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:	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?
36051	Carbon dioxide absorbent	An absorbent material (e.g., granules of treated soda lime) intended to be placed into a reusable carbon dioxide absorber to remove carbon dioxide (CO2) from the exhaled gases in a patient breathing circuit by chemical reaction. It is typically available in large plastic containers [e.g., 5 kilogrammes (Kg) by weight] and poured into clean, reusable absorbers. The absorbent is typically manufactured to change colour during its use (e.g., from white to violet, pink to white, or green to violet) to indicate need for replacement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSF	Absorber, Carbon-Dioxide

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: e9430d30-6cad-41b1-aab6-b5d6a1f43b4e
Public Version Date: February 11, 2025
Public Version Number: 2
DI Record Publish Date: February 01, 2022