FDA.reportPublic FDA data

KoKo

Primary DI
05065016557028
Brand
KoKo
Company
KOKO PFT LTD
Model
Wright Haloscale Respirometer
Catalog number
700-021
Device description
Wright Haloscale Respirometer
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZKSpirometer, Monitoring (W/Wo Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091853000WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014Nspire Health, Inc.2009-09-21BZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852417003279PreviousGS10
05065016557028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852417003279008524170032798524170032790852417003279
05065016557028050650165570285065016557028

GMDN Terms#

Term, Definition table
TermDefinition
Monitoring spirometer, mechanicalA portable mechanical device designed to continuously measure tidal and/or minute volume of a spontaneously-breathing or mechanically-ventilated patient, for the evaluation of the patient’s ventilatory status during intensive care treatment, anaesthesia, and postoperative recovery; it may also be used to measure tidal/minute volume and respiration rate delivered to a patient via the expiratory ports of resuscitation devices to evaluate their performance. It consists of an airflow-driven turbine/dial which indicates the air volume passed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
225828364
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05065016557004KoKoWright Respirometer Mk 8700-0082023-08-01
05065016557011KoKoWright Respirometer Mk 14700-0142023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZK2026-04-15
00851540007161ExSpiron Pediatric PadSetsSenzime AB (Publ.)BZK2024-01-25
05065016557004KoKoKOKO PFT LTDBZK2023-08-01
05065016557011KoKoKOKO PFT LTDBZK2023-08-01
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBZK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyBZK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyBZK2023-04-19
00195278524089NAGE Healthcare Finland OyBZK2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyBZK2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyBZK2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyBZK2022-05-13
00840682104135NAGE Healthcare Finland OyBZK2022-03-07
00840682104302NAGE Healthcare Finland OyBZK2022-03-07
B005001450AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001460AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001470AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001490AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001930AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002900AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002940AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002950AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002960AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002980AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002990AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003010AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003020AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003030AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003050AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003060AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B00500306C0AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31