FDA.reportPublic FDA data

Portex

Primary DI
15019315022357
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/199/085
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315022351PackageGS120In Commercial Distribution
55019315022355PackageGS16In Commercial Distribution
15019315022357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931502235135019315022351
5501931502235555019315022355
1501931502235715019315022357

GMDN Terms#

Term, Definition table
TermDefinition
Infant resuscitation cabinetA small chamber, usually wall-mounted, used for the emergency resuscitation of newborn infants who do not breathe spontaneously at birth and are oxygen deficient. It typically has a front door or lid that folds out to serve as a surface upon which the infant is placed. It is typically equipped with a heating lamp, a low-pressure suction system, an oxygen (O2) supply, a gas mixer (oxygen/air), and a resuscitator. It may be supplied with the resuscitation devices or empty, in which case the resuscitation devices are fitted by another party (e.g., hospital clinical engineer, device supplier).

Regulatory Flags#

DUNS number
118380146
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194226BivonaFT26EN35NSF182N2026-05-27
10887709194233BivonaFU26EN40NGA184N2026-05-27
10887709194240BivonaFT26EN60NSA185N2026-05-27
10887709194356BivonaFT26EN40NSF186N2026-05-27
00887709008045ICU MedicalB33382017-04-17
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194073BivonaHT26ES60NSC163N2026-05-21
10887709194080BivonaFT26EN35NGF164N2026-05-21
10887709194097BivonaFU26EN40NSE165N2026-05-21
10887709194103BivonaFT26EN60NGA166N2026-05-21
10887709194110BivonaFU26EN30NGE167N2026-05-21
10887709194127BivonaFU26EN30NGE170N2026-05-21
10887709194134BivonaFU26EN35NGE169N2026-05-21
00887709102460ICU Medical15687-2815687-282022-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003750396KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750402KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750419KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750426KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750433KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750440KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750457KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750464KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750471KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750488KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
10197344104659MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104666MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104673MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104680MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104697MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104703MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104710MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104727MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104734MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104741MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104758MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104765MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104772MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104789MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104796MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104802MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104819MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104826MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104833MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104840MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12