FDA.reportPublic FDA data

2120 In2itive - Brazil

Primary DI
05099169830127
Brand
2120 In2itive - Brazil
Company
VITALOGRAPH (IRELAND) LIMITED
Model
83012
Catalog number
83012
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K100687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100687000VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120Vitalograph (Ireland) , Ltd.2010-10-16BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05099169830127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05099169830127050991698301275099169830127

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
219683489
Device count
1
Serial number
true
Manufacturing date on label
true

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
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
15099169209890Mouthpiece20202018-05-15

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Primary DI, Brand, Company table
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