FDA.report

ABCAN, SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGE, 1.1L

Primary DI
05030267155804
Brand
ABCAN, SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGE, 1.1L
Company
INTERSURGICAL INCORPORATED
Model
2199001
Device description
ABCAN, SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGE, 1.1L
Published
2021-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BSFAbsorber, Carbon-Dioxide

Product Code Classifications

CodeDeviceSpecialtyClass
BSFAbsorber, Carbon-DioxideAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267155804PackageGS16In Commercial Distribution
05030267155798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267155804050302671558045030267155804
05030267155798050302671557985030267155798

GMDN Terms

TermDefinition
Carbon dioxide absorbentAn 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.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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