DEVICE: Refurbished BG 323 Pump System (B101100516PXSR0)

Device Identifier (DI) Information

Refurbished BG 323 Pump System
100-516PXSR
In Commercial Distribution

CME AMERICA LLC
B101100516PXSR0
HIBCC

1
002125419 *Terms of Use
Refurbished BG323 Pump, Battery 3600 mAh, Wall Charger, Operator's Manual
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General-purpose infusion pump, line-powered A mains electricity (AC-powered) device designed to facilitate the accurate and consistent administration of drugs and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers. The device has a typical flow range of 1 to 999 ml/hour and delivers solutions from a standard infusion bag or bottle of fluid. It typically has internal batteries that enable operation for a short period when no mains electricity is available (e.g., during transportation or a power outage).
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FDA Product Code

[?]
Product Code Product Code Name
MEA Pump, Infusion, Pca
FRN Pump, Infusion
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042696 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -13 and 122 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2b3ca4ec-737c-4729-a5a2-1d990f033d0c
July 06, 2018
3
September 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
303-936-4945
xx@xx.xx
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