DEVICE: T34 Syringe Pump System (B101100100POBSC0)

Device Identifier (DI) Information

T34 Syringe Pump System
100-100POBSC
In Commercial Distribution

CME AMERICA LLC
B101100100POBSC0
HIBCC

1
002125419 *Terms of Use
Pump, 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, battery-powered A battery-powered ambulatory device intended to provide continuous or intermittent administration of non-specific drugs and/or solutions. It consists of a small unit with a pumping mechanism and an infusion-rate controller, and is used with a dedicated single-use medication cartridge (not included). It is used with a suitable injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt or carried in a pocket and may be used in a healthcare setting or in the home.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K080954 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

812d2e4e-259a-4e03-a172-513ee771d553
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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