FDA.reportPublic FDA data

MaxBlend2

Primary DI
00817770025856
Brand
MaxBlend2
Company
MAXTEC, LLC
Model
High Flow
Catalog number
R229P02-010
Device description
MaxBlend2, High Flow 0-15 LPM DISS 50 PSI
Published
2024-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161718000MaxBlend 2, MaxBlend LiteMaxtec, LLC2016-10-27BZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817770025856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817770025856008177700258568177700258560817770025856

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air breathing gas mixer, hospitalAn independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
169911828
Device count
1
Serial number
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

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Primary DI, Brand, Company table
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10889483542798AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
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10889483542859AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542873AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542910AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542958AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
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