FDA.reportPublic FDA data

Medline

Primary DI
10193489019018
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
RFMDO15DHPT2
Catalog number
RFMDO15DHPT2
Device description
FLOWMETER,DUAL OXY,15L,2 PTO,DISS HAND
Published
2021-11-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAXFlowmeter, tube, thorpe, back-pressure compensated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489019018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348901901810193489019018

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, dial-typeA device intended to 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 has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. 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 table
Method

Contacts#

Phone, Email table
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
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970966669167GENTEC®GENTEC(SHANGHAI)CORPORATIONCAX2024-11-16
10193489137644MEDLINEMEDLINE INDUSTRIES, INC.CAX2024-10-08
10193489141108MEDLINEMEDLINE INDUSTRIES, INC.CAX2024-10-08
10193489179545MEDLINEMEDLINE INDUSTRIES, INC.CAX2024-10-08
00848530098513Respiratory AccessorySUNSET HEALTHCARE SOLUTIONS, INC.CAX2024-07-05
10848530101807Celon Wet Bands 30.5 x 25mmSUNSET HEALTHCARE SOLUTIONS, INC.CAX2024-03-20
10848530101814Celon Wet Bands 30.5 x 40mmSUNSET HEALTHCARE SOLUTIONS, INC.CAX2024-03-20
10848530101821Celon Wet Bands 66 x 120mmSUNSET HEALTHCARE SOLUTIONS, INC.CAX2024-03-20
10193489017328MedlineMEDLINE INDUSTRIES, INC.CAX2024-03-05
00810003754660KENTEXKENTRON HEALTHCARE, INC.CAX2024-02-19
00810003754677KENTEXKENTRON HEALTHCARE, INC.CAX2024-02-19
00026072017999PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018002PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018019PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
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00026072018149PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018156PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018163PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22
00026072018170PCALLIED HEALTHCARE PRODUCTS, INC.CAX2023-12-22