FDA.reportPublic FDA data

NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAP

Primary DI
13661657080940
Brand
NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAP
Company
CAIR LGL
Model
NC100C
Device description
NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAP
Published
2026-01-01
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
K171117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171117000Carefusion NeutraClear Needle-free connector (EL-NC1000)Cair Lgl2017-09-01FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23661657080947PackageGS1200In Commercial Distribution
13661657080940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2366165708094723661657080947
1366165708094013661657080940

GMDN Terms#

Term, Definition table
TermDefinition
Neutral-pressure intravenous line needleless valve-connectorA small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point there is minimal fluid flow into or out of the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.

Regulatory Flags#

DUNS number
380834713
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
13661657052329Vesco Medical Nasogastric Feeding TubesVED-99014EO2023-04-26

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Primary DI, Brand, Company table
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07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
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08498840009338VYGONVygon CorporationFPA2020-04-21
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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
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