FDA.reportPublic FDA data

Guerbet Ext/Inj line Straight CT/MR

Primary DI
13661657031058
Brand
Guerbet Ext/Inj line Straight CT/MR
Company
CAIR LGL
Model
PN-MDX3515M
Catalog number
240004
Device description
150 cm Straight Extension/Injection Line for CT & MRI
Published
2023-04-24
Public version status
New
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171118000Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)Cair Lgl2017-08-15FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23661657031055PackageGS125In Commercial Distribution
33661657031052PackageGS1400In Commercial Distribution
53661657031056PackageGS1100In Commercial Distribution
13661657031058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2366165703105523661657031055
3366165703105233661657031052
5366165703105653661657031056
1366165703105813661657031058

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
380834713
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13661657080940NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAPNC100C2026-01-01
1366165708095713,5 CM PE/PVC EXTENSION TUBING WITH 1 NEUTRACLEAR + 1 CLAMP + 1 MOBILE RINGNC1142026-01-01
13661657080971SPYDER QUADRI LUMEN + 4 NEUTRACLEAR + CLAMPNC41412026-01-01
13661657080988SPYDER TRIPLE LUMEN + 3 NEUTRACLEAR + CLAMP D : 2.5MMNC31422026-01-01
13661657080995SPYDER TRIPLE LUMEN + 3 NEUTRACLEAR D : 1MMNC31412026-01-01
13661657081008SPYDER 2 WAYS EXTENSION LINE 10CM D :2.5MM + 2 NEUTRACLEARNC21422026-01-01
23661657080947NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAPNC100C2026-01-01
2366165708095413,5 CM PE/PVC EXTENSION TUBING WITH 1 NEUTRACLEAR + 1 CLAMP + 1 MOBILE RINGNC1142026-01-01
13661657080964SPYDER DOUBLE LUMEN + 2 NEUTRACLEAR + CLAMPSNC21412026-01-01
23661657080978SPYDER QUADRI LUMEN + 4 NEUTRACLEAR + CLAMPNC41412026-01-01
23661657080985SPYDER TRIPLE LUMEN + 3 NEUTRACLEAR + CLAMP D : 2.5MMNC31422026-01-01
23661657080992SPYDER TRIPLE LUMEN + 3 NEUTRACLEAR D : 1MMNC31412026-01-01
23661657081005SPYDER 2 WAYS EXTENSION LINE 10CM D :2.5MM + 2 NEUTRACLEARNC21422026-01-01
13661657051773Vesco Medical Pediatric Nasogastric Feeding TubesVED-86006EO2023-04-26
13661657052237Vesco Medical Nasogastric Feeding TubesVED-94005EO2023-04-26
13661657052244Vesco Medical Nasogastric Feeding TubesVED-94006EO2023-04-26
13661657052251Vesco Medical Nasogastric Feeding TubesVED-94008EO2023-04-26
13661657052275Vesco Medical Nasogastric Feeding TubesVED-99005EO2023-04-26
13661657052305Vesco Medical Nasogastric Feeding TubesVED-99010EO2023-04-26
13661657052312Vesco Medical Nasogastric Feeding TubesVED-99012EO2023-04-26

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Primary DI, Brand, Company table
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04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30