FDA.reportPublic FDA data

Midmark Digital Spirometer w/Calibration Syringe

Primary DI
00841709107931
Brand
Midmark Digital Spirometer w/Calibration Syringe
Company
MIDMARK CORPORATION
Model
4-000-0028
Catalog number
4-000-0028
Device description
The Midmark Digital Spirometer is intended for prescription-use only by physicians and professional medical personnel to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in hospitals and physician/clinician offices. Kit contains: digital spirometer, 10 single mouthpieces, one (1) ten pack of nose clips, calibration syringe.
Published
2020-06-02
Public version status
Update
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
K002499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002499000BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGEBrentwood Medical Technology Corp.2000-11-08BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709107931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709107931008417091079318417091079310841709107931

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerAn electrically-powered device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]. It is an instrument used in a clinical setting with a mouthpiece and tube attached to a computerized unit to process the data from patient ventilatory efforts, volume and/or flow sensors, a display, and usually a graph recorder. The data are compared to standardized values or the patient's former values to help identify or evaluate chronic pulmonary disorders such as asthma, emphysema, or bronchitis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709110337Midmark153603LR-E153603LR-E2020-05-22
00841709110344Midmark153604CE153604CE2020-05-22
00841709110375Midmark153604LRCA-E153604LRCA-E2020-05-22
00841709110382Midmark153604LR-E153604LR-E2020-05-22
00841709111839Midmark153603C153603C2020-05-22
00841709108907Midmark153592-002153592-0022020-10-30
00841709108969Midmark153758-002153758-0022020-10-30
00841709107320Midmark153901-001153901-0012018-05-31
00841709107344Midmark153901-003153901-0032018-05-31
00841709107351Midmark153901-004153901-0042018-05-31
00841709107368Midmark153901-005153901-0052018-05-31
00841709107375Midmark153901-006153901-0062018-05-31
00841709109393Midmark153901-007153901-0072018-05-31
00841709109409Midmark153901-008153901-0082018-05-31
00841709124808Ritter228-001228-0012026-08-27
00841709124815Ritter228-002228-0022026-08-27
00841709124822Ritter228-003228-0032026-08-27
00841709124846Ritter229-002229-0022026-08-27
00841709124853Ritter229-003229-0032026-08-27
00841709125638MidmarkLT-1100-002LT-1100-0022026-07-08

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
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08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990322022MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
14250892909117JaegerJaeger Medical GmbHBZG2025-08-11
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