FDA.reportPublic FDA data

Portex

Primary DI
00351688021031
Brand
Portex
Company
ICU MEDICAL, INC.
Model
4037NP-1
Published
2017-01-04
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
CBTArterial blood sampling kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBTArterial Blood Sampling KitAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K840986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K840986000PREFILLED PULSATOR SYRINGEConcord Laboratories, Inc.1984-04-05CBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30351688021032PackageGS1100In Commercial Distribution
00351688021031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3035168802103230351688021032
00351688021031003516880210313516880210310351688021031

GMDN Terms#

Term, Definition table
TermDefinition
Arterial blood sampling kitA collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
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
10887709204192BivonaZT26IS70NSC117N2026-09-25
10887709204451BivonaSZ26IN60NSB136S2026-09-25
10887709204734BivonaSU26IN45NSZ100N2026-09-25
10887709204901BivonaFT26IN60NGF183N2026-09-25
10887709204918BivonaFT26IN35NGA182N2026-09-25
10887709204925BivonaSF26IN80NSC186N2026-09-25
10887709204932BivonaSF26IN80NSC185N2026-09-25
10887709204949BivonaFT26IN35NGE187N2026-09-25
10887709204826BivonaFT26IN35NSA181N2026-09-24
10887709204833BivonaFT26IN40NGE170N2026-09-24
10887709204840BivonaFT26IN45NGF169N2026-09-24
10887709204857BivonaFT26IN40NGE179N2026-09-24
10887709204864BivonaFT26IN40NGF172N2026-09-24
10887709204871BivonaFT26IN55NGF171N2026-09-24
10887709204888BivonaHU26IS40NGE177N2026-09-24
10887709204895BivonaHU26IS45NGF178N2026-09-24
10887709204505BivonaFU26IN40NGF143N2026-09-22
10887709204512BivonaFU26IN35NGF144N2026-09-22
10887709204550BivonaFU26IN60NSF145N2026-09-22
10887709204680BivonaFU26IN55NSA164N2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160386674MEDLINEMEDLINE INDUSTRIES, INC.CBT2025-03-10
10653160384540MEDLINEMEDLINE INDUSTRIES, INC.CBT2025-01-16
10889483613092A-LineSUNMED, LLCCBT2024-05-17
10889483613108A-LineSUNMED, LLCCBT2024-05-17
10889483613115A-LineSUNMED, LLCCBT2024-05-17
10889483613122PulsetSUNMED, LLCCBT2024-05-17
10889483479407Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479414Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479469Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479476Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479483Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479490Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479506Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483558249Pulset SUNMED, LLCCBT2023-06-30
10889483558256PulsetSUNMED, LLCCBT2023-06-30
10889483558263PulsetSUNMED, LLCCBT2023-06-30
10889483558270PulsetSUNMED, LLCCBT2023-06-30
10889483558287PulsetSUNMED, LLCCBT2023-06-30
10889483558294PulsetSUNMED, LLCCBT2023-06-30
10889483558300PulsetSUNMED, LLCCBT2023-06-30
10889483558317PulsetSUNMED, LLCCBT2023-06-30
10889483558331PulsetSUNMED, LLCCBT2023-06-30
10653160358329MEDLINEMEDLINE INDUSTRIES, INC.CBT2023-01-30
10653160357629MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-12-20
10653160356677MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-11-08
10653160355762MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-10-17
10653160355472MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-27
10653160355144CenturionCENTURION MEDICAL PRODUCTS CORPORATIONCBT2022-09-03
10653160355199MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-03
10653160354338MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-07-22