DEVICE: Clear-View Subcutaneous Infusion Set (M991CVS615101)
Device Identifier (DI) Information
Clear-View Subcutaneous Infusion Set
Clear-View "Sub-Q"
In Commercial Distribution
CVS61510
NORFOLK MEDICAL
Clear-View "Sub-Q"
In Commercial Distribution
CVS61510
NORFOLK MEDICAL
25G x 7mm x 12" Clear-View "Sub-Q" Infusion Set
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? |
---|---|---|---|---|
35833 | Electric infusion pump administration set, single-use |
A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FPA | Set, Administration, Intravascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K870188 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Needle Gauge: 25 Gauge |
Device Record Status
58eacddb-030f-46cb-9094-00ceedb58a37
November 26, 2021
1
November 18, 2021
November 26, 2021
1
November 18, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M991CVS615102 | 8 | M991CVS615101 | In Commercial Distribution | Box | |
M991CVS615103 | 4 | M991CVS615102 | In Commercial Distribution | Case |
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
[?]
8476747075
rgangireddy@norfolkmedical.com
rgangireddy@norfolkmedical.com