FDA.reportPublic FDA data

comPAS2

Primary DI
00851845007248
Brand
comPAS2
Company
VITALOGRAPH (IRELAND) LIMITED
Model
91704
Catalog number
91704
Published
2026-06-03
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
BZGSPIROMETER, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213872000ComPAS2Morgan Scientific, Inc.2022-07-15BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851845007248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851845007248008518450072488518450072480851845007248

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometer, professionalAn electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.

Contacts#

Phone, Email table
PhoneEmail
+1(065)686-4100regulatoryaffairs@vitalograph.ie

Regulatory Flags#

DUNS number
219683489
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
050991693321579100 VITALOGRAPH VitaloLAB+91510915102026-06-02
15099169203102Mouthpiece20202020-06-21
15099169283814PFT28202016-12-01
15099169283821PFT28202016-12-01
050991698301272120 In2itive - Brazil83012830122025-04-30
05099169770508Pneumotrac68002017-11-15
05099169919105VitaloROV91002024-07-31
15099169331898Mouthpiece20202024-04-08
15099169203928Mouthpiece20202018-05-15
15099169251004Aspirator25102018-05-09
65099169688003SPIROTRAC70002021-04-30
15099169202013Mouthpiece20202016-12-08
15099169202020Mouthpiece20202018-05-15
15099169202426Safe-T-Way20242016-12-08
15099169202464Safe-T-Way20242016-12-08
15099169209203Safe-T-Way20242016-12-08
15099169209227Safe-T-Way20242016-12-08
15099169209241Safe-T-Way20242016-12-08
15099169209296Safe-T-Way20242018-05-15
15099169209807Safe-T-Way20242016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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07613365501247PowerCube+ Series Ganshorn Medizin Electronic GmbHBZG2025-03-31
07613365501254PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365500301PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2024-12-20
07613365500400PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2024-12-20