FDA.report

PC

Primary DI
00026072017005
Brand
PC
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
08009-03P
Device description
FLWMTR O2 DISS FHEX 8LPM
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
CACApparatus, Autotransfusion

Product Code Classifications

CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00026072017005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072017005000260720170050260720170050026072017005

GMDN Terms

TermDefinition
Medical gas flowmeter, Thorpe tubeA device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00026072018156PC15008-13T2023-12-22
00026072018163PC15008-13YP2-A2023-12-22
00026072018170PC15009-032023-12-22
00026072018187PC15009-03-A2023-12-22

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