FDA.report

ICU Medical

Primary DI
10887709044484
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
12595-01
Catalog number
12595-01
Device description
Neutron™
Published
2021-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FPASet, administration, intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10887709044484PackageGS1100In Commercial Distribution
00887709044487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770904448410887709044484
00887709044487008877090444878877090444870887709044487

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709188720BivonaAT26CS50NSA182N2026-03-24
10887709188737BivonaAT26CS40NSA180N2026-03-24
10887709188744BivonaAT26CS40NSA181N2026-03-24
10887709188751BivonaAT26CS50NSA183N2026-03-24
10887709188836BivonaSU26CN45NGF194N2026-03-24
10887709188843BivonaSU26CN50NGF193N2026-03-24
10887709188850BivonaFT26CN65NSC192N2026-03-24
10887709188874BivonaFT26CN40NGE196N2026-03-24
10887709188881BivonaFT26CN50NSA199N2026-03-24
10887709188904BivonaHF26CS80NSC198N2026-03-24
10887709188805BivonaSU26CN55NGF1902026-03-23
10887709188812BivonaSU26CN60NSC189N2026-03-23
10887709188829BivonaXT26CS70NSC191N2026-03-23

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10801741239271MiniLocBard Access Systems, Inc.FPA2026-02-26
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00813153028124FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028131FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028148FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028155FRESENIUS KABICodan US CorporationFPA2026-02-05
B2125720502Male Luer Slip PlugINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700B2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700G2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700R2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700V2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700W2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700Y2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
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10801741239189PowerLocBard Access Systems, Inc.FPA2026-01-20
10801741239196MiniLocBard Access Systems, Inc.FPA2026-01-20
10801741239202MiniLocBard Access Systems, Inc.FPA2026-01-20
10817708023418OPTFlowEMED TECHNOLOGIES CORPORATIONFPA2026-01-09
23661657080947NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAPCAIR LGLFPA2026-01-01
2366165708095413,5 CM PE/PVC EXTENSION TUBING WITH 1 NEUTRACLEAR + 1 CLAMP + 1 MOBILE RINGCAIR LGLFPA2026-01-01