DEVICE: Refurbished BodyGuard 121 Twins Pump (B101100105TSAR0)

Device Identifier (DI) Information

Refurbished BodyGuard 121 Twins Pump
100-105TSAR
In Commercial Distribution

CME AMERICA LLC
B101100105TSAR0
HIBCC

1
002125419 *Terms of Use
No description.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Multichannel general-purpose infusion pump A mains electricity (AC-powered) multichannel device designed to facilitate continuous and/or intermittent intravenous (IV) delivery of two or more drugs and/or solutions, via infusion sets, via intravenous routes, but may be delivered via subcutaneous or arterial routes, with independent control of delivery through each channel. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers; has various flow ranges and rates and may use syringes, bags or bottles. It will typically have internal batteries to 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 [?]
Premarket Submission Number Not Available/Not Released
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

7a6ebe27-4aca-4308-ab2b-7efadaab4d7b
March 29, 2018
2
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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