ICU Medical

GUDID 10887709079066

8" (20 cm) Appx 0.37 ml, Smallbore Pressure inf (400psig) Ext Set w/NanoClave® Y-Connector, Purple Clamp, RL

ICU MEDICAL, INC.

Intravenous administration set

• Primary Device ID: 10887709079066
• NIH Device Record Key: 04952e13-07d7-41c9-ac6b-5c1b9434fa8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICU Medical
• Version Model Number: A1116
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709079069 [Primary]
GS1	10887709079066 [Package]; Contains: 00887709079069; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100576

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-11
• Device Publish Date: 2017-04-16

On-Brand Devices [ICU Medical]

• 10887709003214: 72" Smallbore Ext Set, Clamp, Luer Lock
• 10887709002835: 60" (152 cm) Appx 0.4 mL, Smallbore Ext Set w/Clamp, Rotating Luer
• 10887709001432: 9" Transfer Set w/Vented Spike, Female Luer
• 10887709000930: 20" Ext Set, Clamp, Rotating Luer
• 10887709000282: 6" (15 cm) Appx 0.25 mL, Smallbore Ext Set w/Pinch Clamp, Rotating Luer
• 10840619045538: 64" (163cm) APPX 1.9ml, Smallbore Ext Set w/T-Connector, Inj Site, Clamp, Rotating Luer
• 10887709035826: Genie® w/Closed Vial Access Device, Clave®, 10 Units
• 10887709040509: Single Dose Vial Spike
• 10887709086774: 60" (152 cm) Appx 1.8 ml, Smallbore Ext Set w/Clave® T-Connector, Clamp, Rotating Luer
• 10887709085456: 20" Dialysis Ext Set w/Luer Lock
• 10887709085449: 5" Ext Set w/Luer Lock
• 10887709085005: 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Ck vlvs, NanoClave® T-Conn, Clamp, RL
• 10887709084657: 60" (152 cm) Appx 0.45 ml, Smallbore Ext Set w/MicroClave®, Clamp, Check Valve w/Luer Lock
• 10887709084640: 38" (97 cm) Appx 1.2 ml, Smallbore Ext Set w/MicroClave® T-Connector, Clamp, Rotating Luer
• 10887709084633: 16" Blood Set w/170 Micron Filter
• 10887709084626: 7" (18 cm) Appx 0.77 ml, Pressure Infusion (400psig) Ext Set w/Purple Clamp, Rotating Luer
• 10887709084619: 7" (18 cm) Appx 1.6 ml, Bifuse Ext Set w/2 Check Valves, 2 Clamps, Rotating Luer
• 10887709084060: 37" (94 cm) Appx 6.2 ml, 20 Drop Admin Set w/15 Micron Filter, Rotating Luer
• 10887709079097: 115" (292 cm) 10 Drop Primary Set w/3-Port NanoClave® Manifold, 0.2 Micron Filter, 3 Clave® Cl
• 10887709079073: 36" Ext Set, Clamp, Luer Slip
• 10887709079066: 8" (20 cm) Appx 0.37 ml, Smallbore Pressure inf (400psig) Ext Set w/NanoClave® Y-Connector, Pur
• 10887709078823: MC9080
• 10887709078816: 100" (254 cm) Ext Set w/6-Port NanoClave® Manifold, 0.2 Micron Filter, 3 Clave® Clear, Rotatin
• 10887709078366: 6" (15cm) Appx 0.32 ml, Smallbore Ext Set w/T-Connector, Clamp, Rotating Luer
• 10887709078212: 30" PE/PVC Ext Set w/Luer Lock
• 10887709078199: MC9066
• 10887709078182: 234" (594 cm) Appx 13.2 ml, Ext Set w/Clamp, Rotating Luer
• 10887709078175: 5.5" (14 cm) Appx 0.26 ml, Smallbore Pressure inf (400psig) Ext Set w/NanoClave® T-Conn, Purple
• 10887709078168: MC9079
• 10887709078113: 4" (10 cm) Appx 0.67 ml, Smallbore Trifuse Ext Set w/3 NanoClave®, 3 Ck vlvs, 3 Clamps (Red, Ye
• 10887709078106: 13" (33 cm) Appx 0.79 ml, Smallbore Ext Set w/Clave®, 0.2 Micron Filter, Clamp, Rotating Luer
• 10887709078090: 6" Smallbore Ext Set w/0.2 Micron Filter, Clamp, Rotating Luer
• 10887709078083: 4" (10 cm) Appx 0.84 ml, Smallbore Quadfuse Ext Set w/4 Check Valves, 4 Clamps (Red, White, Blue
• 10887709078076: 3" (8 cm) Appx 0.61 ml, Smallbore Trifuse Ext Set w/3 Check Valves, 3 Clamps (Red, Yellow, White
• 10887709078052: 6.5" (17 cm) Appx 0.34 ml, Smallbore Ext Set w/Remv MicroClave®, T-Connector, Clamp, Luer Slip
• 10887709077970: 12" (30 cm) Appx 0.96 ml, Smallbore Trifuse Ext Set w/0.2 Micron Filter, 4 Clamps, Luer Lock
• 10887709077871: 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave®, 0.2 Micron fltr, Clamp, RL
• 10887709077833: 50" Bifuse Blood Set w/170 Micron Filter, 2 Check Valves, Luer Lock
• 10887709077819: 360" (914 cm) Appx 5.8 ml, Smallbore Ext Set w/Clamp, Luer Lock
• 10887709077772: 30" Ext Set w/ChemoLock™, Spiros® w/Red Cap, Priming Cap, Clamp
• 10887709077758: 5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave®, Clamp, Luer Lock
• 10887709077741: 13" Ext Set w/Clave®, Anti-Siphon Valve, Rotating Luer
• 10887709077642: 10" Smallbore Ext Set w/6-Port NanoClave® Manifold, Check Valve, Clamp, Rotating Luer
• 10887709077635: ChemoLock™ Bag Spike Additive Port, Female Luer
• 10887709077550: SC168
• 10887709077543: SC167
• 10887709077512: 14" (36 cm) Ext Set w/7 Gang 4-Way Stopcocks w/Baseplate, Rotating Luer (Male/Male)
• 10887709077505: 3.5" (9 cm) Appx 0.53 ml, Smallbore Trifuse Ext Set w/3 Clamps (Yellow, White, Red), Rotating Lu
• 10887709077420: SC166
• 10887709077390: 6" (15 cm) Appx 0.53 ml, Smallbore Trifuse Ext Set w/2 MicroClave®, 3 Clamps, Rotating Luer