In-Check

Primary DI
05023323000804
Brand
In-Check
Company
CLEMENT CLARKE INTERNATIONAL LIMITED
Model
3109831
Catalog number
3109831
Device description
IN-CHECK M
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZHMeter, Peak Flow, Spirometry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZHMeter, Peak Flow, SpirometryAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980960000IN-CHECK INSPIRATORY FLOWMETERClement Clarke Intl., Ltd.1998-06-10BZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05023323000804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05023323000804050233230008045023323000804

GMDN Terms#

Term, Definition table
TermDefinition
Incentive spirometerA hand-held, mechanical, breathing-muscle exerciser used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It typically includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility or in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401279414969twhay@ccholdingsltd.com

Regulatory Flags#

DUNS number
216155952
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
05023323000941Mini Wright310412431041242016-09-07
05023323030054VentiChamber036-00-050U2024-10-24
05023323029959VentiChamber036-00-010U2024-10-07
05023323029973VentiChamber036-01-010U2024-10-07
05023323029997VentiChamber036-01-020U2024-10-07
05023323030023VentiChamber036-01-030U2024-10-07
05023323029799InspiraChamber® 100110S2024-05-29
05023323029812InspiraChamber® 100110M2024-05-29
05023323029829InspiraChamber® 100110L2024-05-29
05023323029768InspiraChamber® 1001102024-05-24
05023323029782InspiraChamber® 1001502024-05-24
05023323000354In-Check310999331099932016-09-07
05023323000361In-Check310975131097512016-09-07
05023323000408In-Check310975031097502016-09-07
05023323000897In-Check310930031093002016-09-07
05023323001146In-Check3109750ATM3109750ATM2016-09-07
05023323001153In-Check3109912ATM3109912ATM2016-09-07
05023323001177In-Check310991031099102016-09-07
05023323028860Clement Clarke International31220652022-12-05
05023323029454Clement Clarke International31220622022-12-05

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