FDA.reportPublic FDA data

Medline

Primary DI
10888277652460
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ760ELB
Catalog number
DYNJ760ELB
Device description
FILTER,PULMONARY,FUNCTION,ELLIPTICAL,BLU
Published
2021-07-14
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
20888277652467PackageGS1100In Commercial Distribution
10888277652460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827765246720888277652467
1088827765246010888277652460

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function testing filter/mouthpieceA non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.

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
10193489135909MEDLINEDYNJP2228SGDYNJP2228SG2026-07-17
10197344112722MEDLINESSBCS23GTSSBCS23GT2026-07-17
10197344157174MEDLINESNAPSECUREPSNAPSECUREP2026-07-17
10197344169450MEDLINEMSCSRG9736MSCSRG97362026-07-17
10197344205141MEDLINEMSC608ASXLMSC608ASXL2026-07-17
10197344216116MEDLINESSBCS21GSSBCS21G2026-07-17
10197344216130MEDLINESSBCS21GTSSBCS21GT2026-07-17
10197344216147MEDLINESSBCS23GSSBCS23G2026-07-17
10197344216154MEDLINESSBCS23GLSSBCS23GL2026-07-17
10197344216161MEDLINESSBCS25GSSBCS25G2026-07-17
10197344216178MEDLINESSBCS25GLSSBCS25GL2026-07-17
10197344216185MEDLINESSBCS25GTSSBCS25GT2026-07-17
10884389362020MEDLINEDYNJSMD01DYNJSMD012026-07-17
10888277407954MEDLINEOR87VOR87V2026-07-17
20193489029939MEDLINEMDTZ1020872GHMDTZ1020872GH2026-07-17
20193489029953MEDLINEMDTZ1020872GJMDTZ1020872GJ2026-07-17
20197344033925MEDLINEMLABDISH35MLABDISH352026-07-17
20197344033956MEDLINEMLABDISH65MLABDISH652026-07-17
20197344219428MEDLINEMDT2168054XGVMDT2168054XGV2026-07-17
20197344219442MEDLINEMDT2168104GVMDT2168104GV2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613365501247PowerCube+ Series Ganshorn Medizin Electronic GmbHBZG2025-03-31