- Physicians Office Resource

SCB APEX 250ML SINGLE PACK
APEX® - 2112618

Device Description

An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Capacity (ml) : 250.000 ML

Capacity (ml) : 250.000 ML

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: KPE

Device Name: Container, I.V.

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5025

Third Party Flag: Y

Medical Specialty: HO

Device Identifiers

Device Id: 04046955734733

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04046955734726

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 04046955734726

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

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