FDA.reportPublic FDA data

Pneupac

Primary DI
10610586038280
Brand
Pneupac
Company
ICU MEDICAL, INC.
Model
122004
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CBKVENTILATOR, CONTINUOUS, FACILITY USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970158000BABYPACPneupac, Inc.1998-04-28CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30610586038284PackageGS115In Commercial Distribution
10610586038280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061058603828430610586038284
1061058603828010610586038280

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197395BivonaFU26FN35NGE250N2026-07-06
10887709197401BivonaFU26FN30NGE251N2026-07-06
10887709197418BivonaSU26FN80NSC252N2026-07-06
10887709197425BivonaFT26FN45NGC256N2026-07-06
10887709197432BivonaFU26FN50NGC254N2026-07-06
10887709197449BivonaFT26FN50NGC255N2026-07-06
10887709197456BivonaFT26GN35NGE001N2026-07-06
10887709197463BivonaFT26GN40NGE002N2026-07-06
10887709197470BivonaFT26GN35NSA003N2026-07-06
10887709197487BivonaFU26GN40NSF004N2026-07-06
10887709197494BivonaXA26GS60NSC005N2026-07-06
10887709197500BivonaSA26GN60NSC006N2026-07-06
10887709197517BivonaSA26GN60NSC007N2026-07-06
10887709197524BivonaSA26GN60NSC008N2026-07-06
10887709197531BivonaSA26GN60NSC009N2026-07-06
10887709197548BivonaST26GN60NSC010N2026-07-06
10887709197555BivonaFU26GN50NSF011N2026-07-06
10887709197562BivonaFU26GN50NSF012N2026-07-06
10887709197579BivonaFT26GN35NGF013N2026-07-06
15019517382860ICU Medical, Inc.011-100/892/200CZ2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198843002876bellavistaZoll Medical CorporationCBK2026-07-06
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676247DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676254DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676261DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676377DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676384DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
10889483603987AirLife™AIRLIFECBK2025-02-26
10889483603994AirLife™AIRLIFECBK2025-02-26
10889483604007AirLife™AIRLIFECBK2025-02-26
10889483604045AirLife™AIRLIFECBK2025-02-26
10889483604052AirLife™AIRLIFECBK2025-02-26
10889483604069AirLife™AIRLIFECBK2025-02-26
10889483604076AirLife™AIRLIFECBK2025-02-26
10889483604083AirLife™AIRLIFECBK2025-02-26