FDA.reportPublic FDA data

Level 1

Primary DI
50695085800222
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
7204018
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL
CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50695085800222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5069508580022250695085800222

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pressure infusor, automatedA pneumatically-powered device designed to increase the rate of an intravenous (IV) infusion given to a patient by applying pressure directly to the infusion bag. The device is designed with a pressure chamber into which the infusion bag is secured, and is connected to a supply of pressurized air which, when activated, creates pressure in the rear of the chamber. It typically includes a pressure gauge to indicate the applied pressure and overpressure safety features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09
10887709197883BivonaFU26GN35NGE044N2026-07-09
10887709197890BivonaFU26GN30NGE045N2026-07-09
10887709197906BivonaFP26GN25NGE046N2026-07-09
10887709197135BivonaXT26FS60NGC231N2026-07-08
10887709197142BivonaFT26FN35NGC234N2026-07-08
10887709197203BivonaFT26FN55NGC237N2026-07-08
10887709197210BivonaFT26FN35NSF236N2026-07-08
10887709197227BivonaFT26FN40NGE238N2026-07-08
10887709197234BivonaFT26FN40NGE239N2026-07-08
10887709197241BivonaFT26FN60NGC240N2026-07-08
10887709197722BivonaHT26GS70NSC029N2026-07-08
10887709197739BivonaFT26GN35NSE030N2026-07-08
10887709197746BivonaFT26GN30NSF031N2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483564134BALLARD™SUNMED, LLCBSY2026-07-09
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
06925816656057Suction CatheterWell Lead Medical Co.,LtdBSY2026-06-03
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10080196033553MEDLINEMEDLINE INDUSTRIES, INC.BSY2026-05-15
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
10889483564325BALLARD™SUNMED, LLCBSY2025-11-20
10889483623411BALLARD™SUNMED, LLCBSY2025-11-20
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10080196033331MEDLINEMEDLINE INDUSTRIES, INC.BSY2025-06-12
10080196033348MEDLINEMEDLINE INDUSTRIES, INC.BSY2025-06-12
10080196033362MEDLINEMEDLINE INDUSTRIES, INC.BSY2025-06-12
10080196033355MEDLINEMEDLINE INDUSTRIES, INC.BSY2025-05-29
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
10192253040166ArgyleCardinal Health 200, LLCBSY2024-08-20
10192253040173ArgyleCardinal Health 200, LLCBSY2024-08-20
10192253042368ArgyleCardinal Health 200, LLCBSY2024-08-20
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13