FDA.reportPublic FDA data

BlenderBuddy

Primary DI
00817770022350
Brand
BlenderBuddy
Company
MAXTEC, LLC
Model
BlenderBuddy
Catalog number
R219P20-001
Device description
Precision Medical BlenderBuddy with Flowmeter
Published
2021-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00817770022350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817770022350008177700223508177700223500817770022350

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
169911828
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817770026068Pressure Monitoring Line with Nafion Dryer (BioMed Private Label)R229P18-0012025-07-21
00817770020691HANDI+R218P122016-09-26
00817770020707HANDI+R218P12-0012018-03-27
00817770020868Handi+ R218P12-0052016-09-24
00817770021322HANDI+, OHIO MEDICALR218P12-0122017-02-20
00817770021339HANDI+ INTERNATIONALR218P12-013R218P12-0132017-02-20
00817770024460Dual Hose10' Air/OxygenR129P272021-10-29
00817770022299Coiled Hose15 foot OxygenR127P402021-10-22
00817770024378Dual Hose10' Air/OxygenR129P182021-10-22
00817770024385Dual Hose10' Air/OxygenR129P192021-10-22
00817770024392Dual Hose10' Air/OxygenR129P202021-10-22
00817770024408Dual Hose15' Air/OxygenR129P292021-10-22
00817770024415Dual Hose15' Air/OxygenR129P222021-10-22
00817770024422Dual Hose15' Air/OxygenR129P232021-10-22
00817770024439Dual Hose15' Air/OxygenR129P242021-10-22
00817770024446Dual Hose10' Air/OxygenR129P252021-10-22
00817770024453Dual Hose10' Air/OxygenR129P262021-10-22
00817770024477Dual Hose6' Air/OxygenR129P502021-10-22
00817770024484Dual Hose6' Air/OxygenR129P512021-10-22
00817770024491Dual Hose6' Air/OxygenR129P522021-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592346652187Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652194Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652200Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652217Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652224Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692329Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692404Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692442Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692466Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692503Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346696914Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346705302Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346732926Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782013Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782020Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782075Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782655Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782723Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782730Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346815858Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893153Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893160Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893177Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893184Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893191Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893207Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346905603Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346905665Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346997752Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346997769Amvex FlowmeterGCE, s.r.o.CAX2026-07-07