FDA.report

PC

Primary DI
40026072025282
Brand
PC
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
55-01-0019
Device description
LITHOLYME,DRAGERSTYLE,6/CS
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CBLAbsorbent, Carbon-Dioxide

Product Code Classifications

CodeDeviceSpecialtyClass
CBLAbsorbent, Carbon-DioxideAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40026072025282PackageGS16In Commercial Distribution
00026072025284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4002607202528240026072025282
00026072025284000260720252840260720252840026072025284

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

Regulatory Flags

DUNS number
099674145
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
true
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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00026072018163PC15008-13YP2-A2023-12-22
00026072018170PC15009-032023-12-22
00026072018187PC15009-03-A2023-12-22

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