DEVICE: Axiom® Uni-Sump (M6651111770)
Device Identifier (DI) Information
Axiom® Uni-Sump
111177
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
111177
In Commercial Distribution
AXIOM MEDICAL, INCORPORATED
Sump Drain, Two Lumens, Silicone, Small Eye
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
15270 | Sump drain |
A sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K771048 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 6.5 Millimeter |
Length: 12 Inch |
Device Record Status
12520bae-1ae3-4281-b289-349488cc53bf
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 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 |
---|---|---|---|---|---|
M6651111773 | 10 | M6651111771 | In Commercial Distribution | Case | |
M6651111771 | 10 | M6651111770 | In Commercial Distribution | Box |
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
[?]
310-533-9020
Sales@AxiomMed.com
Sales@AxiomMed.com