FDA.reportPublic FDA data

Medline

Primary DI
10888277652392
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ758BMN
Catalog number
DYNJ758BMN
Device description
FILTER,NOSECLIP,MOUTHPIECE
Published
2021-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSPIROMETER, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042758000POLYTECH PULMONARY FUNCTION FILTERPolytechnic Resources, Inc.2005-08-29BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277652399PackageGS1100In Commercial Distribution
10888277652392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827765239920888277652399
1088827765239210888277652392

GMDN Terms#

Term, Definition table
TermDefinition
Progastrin-releasing peptide (ProGRP) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progastrin-releasing peptide (ProGRP) in a clinical specimen, using a fluorescent immunoassay method.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04057155000924SpiroWayeResearchTechnology GmbHBZG2026-08-14
05056845200278Spiroguard Noseclip-Cheek holderGVS FILTER TECHNOLOGY UK LTDBZG2026-06-26
00851845007248comPAS2VITALOGRAPH (IRELAND) LIMITEDBZG2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZG2026-06-02
07640142190554EasyOne Sky SpirometerNDD Medizintechnik AGBZG2026-04-21
08052990320288MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320295MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320363MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320370MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320387MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320431MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320455MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320462MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320509MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320516MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320547MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320554MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990322022MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
14250892909117JaegerJaeger Medical GmbHBZG2025-08-11
050991698301272120 In2itive - BrazilVITALOGRAPH (IRELAND) LIMITEDBZG2025-04-30
07613365501193PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501209PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501216PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501223PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501230PowerCube+ Series Ganshorn Medizin Electronic GmbHBZG2025-03-31