AccessGUDID - DEVICE: Medisorb™ (10889483583364)

GUDID

Device Identifier (DI) Information

Brand Name: Medisorb™
Version or Model: 427000100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 427000100
Company Name: AirLife Finland Oy

Primary DI Number: 10889483583364
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368457563 *Terms of Use

Device Description: Medisorb™ Pre-Packed Rounds, Disposable

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:	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?
46233	Carbon dioxide absorbent cartridge	A non-sterile, prefilled, sealed container (cartridge or drum) containing a carbon dioxide absorbent material (e.g., granules of treated soda lime) intended to be inserted into a reusable anaesthesia system absorber for the removal of carbon dioxide (CO2) exhaled by a patient into an anaesthesia unit/workstation breathing circuit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBL	Absorbent, 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
Storage Environment Temperature: between 0 and 35 Degrees Celsius
Storage Environment Temperature: between 32 and 95 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Fragile, handle with care

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 248c5569-80ae-4f63-b134-3d6e099938ba
Public Version Date: April 30, 2025
Public Version Number: 1
DI Record Publish Date: April 22, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20889483583361	12	10889483583364		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (800)433-2797
Email: info@sun-med.com

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