DEVICE: MediBag (00857595005848)
Device Identifier (DI) Information
MediBag
220530
In Commercial Distribution
220530
SUMMIT MEDICAL PRODUCTS, INC.
220530
In Commercial Distribution
220530
SUMMIT MEDICAL PRODUCTS, INC.
MediBag - 500 mL - Dual Port (Needleless and Spike Ports)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
35188 | Parenteral/enteral solution bag |
A flexible pouch or sack designed to contain a solution of nutrients or medication for administration to a patient either parenterally (e.g., intravenously) or enterally (directly into the gastrointestinal tract). It is typically made of synthetic polymer materials. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KPE | Container, I.V. |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K001287 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 500 Milliliter |
Device Record Status
541b4c9f-a430-4dfb-b508-e02b6df0c4b1
September 13, 2019
1
September 05, 2019
September 13, 2019
1
September 05, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20857595005842 | 60 | 10857595005845 | In Commercial Distribution | ||
10857595005845 | 30 | 00857595005848 | In Commercial Distribution |
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
[?]
(801) 352-1888
service@ambitpump.com
service@ambitpump.com