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
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

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