FDA.reportPublic FDA data

Portex

Primary DI
10788942540903
Brand
Portex
Company
ICU MEDICAL, INC.
Model
55-4090
Published
2016-10-11
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
BYIPERCUSSOR, POWERED-ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50788942540901PackageGS140In Commercial Distribution
10788942540903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5078894254090150788942540901
1078894254090310788942540903

GMDN Terms#

Term, Definition table
TermDefinition
Manual chest percussorA hand-held device designed to facilitate manual percussion (rapid tapping) to provide external vibrations to the chest wall of a patient (neonate to adult) to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It is typically made of soft plastic, in the shape of a cup with a short handle, and available in a range of sizes. This a reusable device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709206905BivonaFU26JN40NSC136N2026-10-20
10887709206912BivonaFT26JN35NSE138N2026-10-20
10887709206936BivonaFT26JN60NSF126N2026-10-20
10887709206950BivonaFU26JN30NSE134N2026-10-20
10887709206967BivonaFU26JN35NSE135N2026-10-20
10887709206974BivonaFU26JN30NSF137N2026-10-20
10887709206981BivonaFT26JN40NSE142N2026-10-20
10887709206998BivonaFT26JN35NSE143N2026-10-20
10887709207001BivonaSU26JN50NSB144N2026-10-20
10887709206776BivonaFT26JN55NGC127N2026-10-19
10887709206783BivonaXT26JS60NGC132N2026-10-19
10887709206813BivonaXT26JS40NGF130N2026-10-19
10887709206844BivonaFT26JN30NGF129N2026-10-19
10887709206851BivonaFT26JN60NSC131N2026-10-19
10887709206868BivonaFU26JN45NGA115N2026-10-19
10887709206875BivonaFT26JN35NGF133N2026-10-19
10887709206882BivonaSA26JN70NSC097N2026-10-19
10887709206899BivonaFU26HN40NGF206S2026-10-19
10887709206646BivonaSA26JN95NSC113N2026-10-16
10887709206653BivonaHA26JS85NSC114N2026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B102125003S1200SmartVestELECTROMED, INC.BYI2026-10-05
00841470100841PercussorPULMODYNE INCBYI2026-05-29
00841470100858PercussorPULMODYNE INCBYI2026-05-29
00816305024890AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024906AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024913AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024920AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024937AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025101AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025248AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025255AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025262AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025279AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025286AffloVestTactile Systems Technology, Inc.BYI2026-05-27
10889483563113BALLARD™SUNMED, LLCBYI2025-12-01
30889483563117BALLARD™SUNMED, LLCBYI2025-12-01
00606959420540inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420557inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420564inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420571inCourage®Respiratory Technologies, Inc.BYI2025-09-17
B102090700S0100SmartVestELECTROMED, INC.BYI2025-07-02
07290020062000LibAirty Airway Clearance SystemSYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062017LibAirty Airway Clearance System Vest (S)SYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062024LibAirty Airway Clearance System Vest (M)SYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062031LibAirty Airway Clearance System Vest (L)SYNCHRONY MEDICAL LTDBYI2025-05-19
B102125003S0110SmartVestELECTROMED, INC.BYI2025-03-19
B102125003S0311SmartVestELECTROMED, INC.BYI2025-01-21
B102125003S0411SmartVestELECTROMED, INC.BYI2025-01-21
00887761976849The Vest®SystemHILL-ROM SERVICES PTE. LTD.BYI2024-12-20
00887761967243The Vest APX SystemHILL-ROM SERVICES PTE. LTD.BYI2024-09-06