i-STAT 06P17-15

GUDID 00054749001231

i-STAT ACT, CONTROL LEVEL 1

ABBOTT POINT OF CARE INC.

Activated clotting time (ACT) IVD, control

• Primary Device ID: 00054749001231
• NIH Device Record Key: b7c88466-6579-4f39-8011-ca1a2c0a3402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-STAT
• Version Model Number: 06P17-15
• Catalog Number: 06P17-15
• Company DUNS: 079226216
• Company Name: ABBOTT POINT OF CARE INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00054749001231 [Primary]
GS1	10054749001238 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120900

FDA Product Code

• GGN: PLASMA, COAGULATION CONTROL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

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• 00054749003907: i-STAT 1 Analyzer, Immuno Ready
• 00054749003891: i-STAT 1 Analyzer, Immuno Ready
• 00054749003884: i-STAT 1 Analyzer, Immuno Ready
• 00054749003877: i-STAT 1 Analyzer, Immuno Ready
• 00054749003860: i-STAT 1 Analyzer, Immuno Ready
• 00054749003853: i-STAT 1 Analyzer, Immuno Ready
• 00054749003846: i-Stat 1 Wireless Analyzer
• 00054749003839: i-Stat 1 Wireless Analyzer
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• 00054749003815: i-Stat 1 Wireless Analyzer
• 00054749003808: i-Stat 1 Wireless Analyzer
• 00054749003792: i-Stat 1 Wireless Analyzer
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• 00054749003778: i-STAT 1 Analyzer, Immuno Ready
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• 00054749003754: i-STAT 1 Analyzer, Immuno Ready
• 00054749003747: i-STAT 1 Analyzer, Immuno Ready
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• 00054749003587: i-Stat 1 Wireless Analyzer
• 00054749003402: i-Stat 1 Wireless Analyzer
• 00054749003396: i-Stat 1 Wireless Analyzer
• 00054749003389: i-Stat 1 Wireless Analyzer
• 00054749003372: i-Stat 1 Wireless Analyzer
• 00054749003365: i-Stat 1 Wireless Analyzer
• 00054749003358: i-Stat 1 Wireless Analyzer
• 00054749003044: i-Stat 1 Wireless Analyzer
• 00054749002528: i-Stat 1 Wireless Analyzer
• 00054749001408: i-Stat 1 Wireless Analyzer
• 00054749001262: MILITARY KIT
• 00054749001248: i-STAT ACT, CONTROL LEVEL 2
• 00054749001231: i-STAT ACT, CONTROL LEVEL 1
• 00054749001224: i-STAT PT, CONTROL LEVEL 2
• 00054749001217: i-STAT PT, CONTROL LEVEL 1
• 00054749000340: i-STAT 1 Analyzer, Immuno Ready
• 00054749005093: i-STAT 1 Wireless
• 00054749005512: Cartridge, Chem8+
• 00054749005529: i-STAT 1 Wireless
• 00054749005222: i-Stat 1 Wireless Analyzer
• 00054749005215: i-Stat 1 Wireless Analyzer
• 00054749005208: i-Stat 1 Wireless Analyzer
• 00054749005192: i-Stat 1 Wireless Analyzer
• 00054749005185: i-Stat 1 Wireless Analyzer
• 00054749005178: i-Stat 1 Wireless Analyzer
• 00054749005161: i-Stat 1 Wireless Analyzer