FDA.report

SPHERASORB W-V CO2 ABSORBENT 1KG

Primary DI
05030267018826
Brand
SPHERASORB W-V CO2 ABSORBENT 1KG
Company
INTERSURGICAL INCORPORATED
Model
2173000
Device description
SPHERASORB W-V CO2 ABSORBENT 1KG
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
CBLAbsorbent, Carbon-Dioxide

Product Code Classifications

CodeDeviceSpecialtyClass
CBLAbsorbent, Carbon-DioxideAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267018826PackageGS110In Commercial Distribution
05030267063574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267018826050302670188265030267018826
05030267063574050302670635745030267063574

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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