FDA.report

Midmark IQspiro Digital Spirometer

Primary DI
00841709100345
Brand
Midmark IQspiro Digital Spirometer
Company
MIDMARK CORPORATION
Model
4-000-0025
Catalog number
4-000-0025
Device description
The IQspiro Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQspiro is for use in hospitals and physician/clinician offices by individuals that have received instruction or training in the administration of spirometry tests. The IQspiro operates with a Windows-compatible computer using a USB port connection and the Midmark software. Kit includes: Midmark IQspiro Digital Spirometer, 10 Disposable Spirometer Mouthpieces, 10 Disposable Nose clips, and Carrying Case.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BZGSpirometer, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841709100345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709100345008417091003458417091003450841709100345

GMDN Terms

TermDefinition
Diagnostic spirometerA mains electricity (AC-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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Avoid extreme humidity and temperatures during use and storage, keep dry, keep away from direct sunlight.
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1-(800)624-8950techsupport@midmark.com

Regulatory Flags

DUNS number
005036025
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00841709121951MidmarkLT-1400-114LT-1400-1142026-03-10
00841709121968MidmarkLT-1400-120LT-1400-1202026-03-10
00841709121975MidmarkLT-1400-126LT-1400-1262026-03-10
00841709121982MidmarkLT-1400-132LT-1400-1322026-03-10
00841709121999MidmarkLT-1500-096LT-1500-0962026-03-10
00841709122002MidmarkLT-1500-102LT-1500-1022026-03-10
00841709122019MidmarkLT-1500-108LT-1500-1082026-03-10
00841709122026MidmarkLT-1500-114LT-1500-1142026-03-10
00841709122033MidmarkLT-1500-120LT-1500-1202026-03-10

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