- Physicians Office Resource

IST DISPENSING TIP
i-STAT - 06F24-16

Device Description

A hand-held manual device intended to be used to obtain a specimen of blood, blood components (e.g., platelets), or blood culture from a specimen receptacle, and facilitate its transfer to another receptacle [e.g., evacuated blood collection tube] for subsequent analysis. It consists of a spike/needle for sampling the specimen through the sealed stopper of the receptacle (i.e., without opening the receptacle), and is designed to reduce the risk of user exposure to the specimen and spike/needle [e.g., has a plastic housing for guarding the needle]. This is a single-use device.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: JRC

Device Name: Micro Pipette

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.2050

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 00054749001385

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 10054749001382

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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