DEVICE: Purple NeoFeed Pump (B101100110PSLA0)
Device Identifier (DI) Information
Purple NeoFeed Pump
100-110PSLA
Not in Commercial Distribution
CME AMERICA LLC
100-110PSLA
Not in Commercial Distribution
CME AMERICA LLC
Pump, Wall Charger, Operator's Manual
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
13217 | Bedside syringe pump |
A mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MEA | Pump, Infusion, Pca |
FRN | Pump, Infusion |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -13 and 122 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
454154eb-731e-4cc6-8279-31c3ce1d31e6
June 17, 2022
6
September 15, 2016
June 17, 2022
6
September 15, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
303-936-4945
xx@xx.xx
xx@xx.xx