FDA.report

MEDLINE

Primary DI
20193489081630
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJAACO2BAG
Catalog number
DYNJAACO2BAG
Device description
ABSORBER, CO2, BAG, 1.5L
Published
2024-10-25
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
true

Related Records

Contact Domains

Product Codes

CodeName
CBLABSORBENT, CARBON-DIOXIDE

Product Code Classifications

CodeDeviceSpecialtyClass
CBLAbsorbent, Carbon-DioxideAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489081630PackageGS112In Commercial Distribution
10193489081633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348908163020193489081630
1019348908163310193489081633

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Fragile, handle with care. Keep from freezing.
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
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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