ICU Medical

GUDID 10887709019321

138" 10 Drop 24 Hour Primary Set w/3 Bravo24®, 3 Gang 4-Way Stopcocks, Luer Lock, 1 Ext

ICU MEDICAL, INC.

Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive
Primary Device ID10887709019321
NIH Device Record Key6c4ba14c-54e8-4385-882e-7e3bda5c2ed2
Commercial Distribution StatusIn Commercial Distribution
Brand NameICU Medical
Version Model NumberB99191
Company DUNS118380146
Company NameICU MEDICAL, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100887709019324 [Primary]
GS110887709019321 [Package]
Contains: 00887709019324
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMGStopcock, i.V. Set

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-12-11
Device Publish Date2017-04-23

On-Brand Devices [ICU Medical]

1088770900321472" Smallbore Ext Set, Clamp, Luer Lock
1088770900283560" (152 cm) Appx 0.4 mL, Smallbore Ext Set w/Clamp, Rotating Luer
108877090014329" Transfer Set w/Vented Spike, Female Luer
1088770900093020" Ext Set, Clamp, Rotating Luer
108877090002826" (15 cm) Appx 0.25 mL, Smallbore Ext Set w/Pinch Clamp, Rotating Luer
1084061904553864" (163cm) APPX 1.9ml, Smallbore Ext Set w/T-Connector, Inj Site, Clamp, Rotating Luer
10887709035826Genie® w/Closed Vial Access Device, Clave®, 10 Units
10887709040509Single Dose Vial Spike
1088770908677460" (152 cm) Appx 1.8 ml, Smallbore Ext Set w/Clave® T-Connector, Clamp, Rotating Luer
1088770908545620" Dialysis Ext Set w/Luer Lock
108877090854495" Ext Set w/Luer Lock
10887709085005107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Ck vlvs, NanoClave® T-Conn, Clamp, RL
1088770908465760" (152 cm) Appx 0.45 ml, Smallbore Ext Set w/MicroClave®, Clamp, Check Valve w/Luer Lock
1088770908464038" (97 cm) Appx 1.2 ml, Smallbore Ext Set w/MicroClave® T-Connector, Clamp, Rotating Luer
1088770908463316" Blood Set w/170 Micron Filter
108877090846267" (18 cm) Appx 0.77 ml, Pressure Infusion (400psig) Ext Set w/Purple Clamp, Rotating Luer
108877090846197" (18 cm) Appx 1.6 ml, Bifuse Ext Set w/2 Check Valves, 2 Clamps, Rotating Luer
1088770908406037" (94 cm) Appx 6.2 ml, 20 Drop Admin Set w/15 Micron Filter, Rotating Luer
10887709079097115" (292 cm) 10 Drop Primary Set w/3-Port NanoClave® Manifold, 0.2 Micron Filter, 3 Clave® Cl
1088770907907336" Ext Set, Clamp, Luer Slip
108877090790668" (20 cm) Appx 0.37 ml, Smallbore Pressure inf (400psig) Ext Set w/NanoClave® Y-Connector, Pur
10887709078823MC9080
10887709078816100" (254 cm) Ext Set w/6-Port NanoClave® Manifold, 0.2 Micron Filter, 3 Clave® Clear, Rotatin
108877090783666" (15cm) Appx 0.32 ml, Smallbore Ext Set w/T-Connector, Clamp, Rotating Luer
1088770907821230" PE/PVC Ext Set w/Luer Lock
10887709078199MC9066
10887709078182234" (594 cm) Appx 13.2 ml, Ext Set w/Clamp, Rotating Luer
108877090781755.5" (14 cm) Appx 0.26 ml, Smallbore Pressure inf (400psig) Ext Set w/NanoClave® T-Conn, Purple
10887709078168MC9079
108877090781134" (10 cm) Appx 0.67 ml, Smallbore Trifuse Ext Set w/3 NanoClave®, 3 Ck vlvs, 3 Clamps (Red, Ye
1088770907810613" (33 cm) Appx 0.79 ml, Smallbore Ext Set w/Clave®, 0.2 Micron Filter, Clamp, Rotating Luer
108877090780906" Smallbore Ext Set w/0.2 Micron Filter, Clamp, Rotating Luer
108877090780834" (10 cm) Appx 0.84 ml, Smallbore Quadfuse Ext Set w/4 Check Valves, 4 Clamps (Red, White, Blue
108877090780763" (8 cm) Appx 0.61 ml, Smallbore Trifuse Ext Set w/3 Check Valves, 3 Clamps (Red, Yellow, White
108877090780526.5" (17 cm) Appx 0.34 ml, Smallbore Ext Set w/Remv MicroClave®, T-Connector, Clamp, Luer Slip
1088770907797012" (30 cm) Appx 0.96 ml, Smallbore Trifuse Ext Set w/0.2 Micron Filter, 4 Clamps, Luer Lock
108877090778718.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave®, 0.2 Micron fltr, Clamp, RL
1088770907783350" Bifuse Blood Set w/170 Micron Filter, 2 Check Valves, Luer Lock
10887709077819360" (914 cm) Appx 5.8 ml, Smallbore Ext Set w/Clamp, Luer Lock
1088770907777230" Ext Set w/ChemoLock™, Spiros® w/Red Cap, Priming Cap, Clamp
108877090777585.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave®, Clamp, Luer Lock
1088770907774113" Ext Set w/Clave®, Anti-Siphon Valve, Rotating Luer
1088770907764210" Smallbore Ext Set w/6-Port NanoClave® Manifold, Check Valve, Clamp, Rotating Luer
10887709077635ChemoLock™ Bag Spike Additive Port, Female Luer
10887709077550SC168
10887709077543SC167
1088770907751214" (36 cm) Ext Set w/7 Gang 4-Way Stopcocks w/Baseplate, Rotating Luer (Male/Male)
108877090775053.5" (9 cm) Appx 0.53 ml, Smallbore Trifuse Ext Set w/3 Clamps (Yellow, White, Red), Rotating Lu
10887709077420SC166
108877090773906" (15 cm) Appx 0.53 ml, Smallbore Trifuse Ext Set w/2 MicroClave®, 3 Clamps, Rotating Luer

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