DEVICE: 5-Pack, 100 cc Syringe, Luer-locking (00851607003518)
Device Identifier (DI) Information
5-Pack, 100 cc Syringe, Luer-locking
RMD-010-016
In Commercial Distribution
MEDSPIRA, LLC
RMD-010-016
In Commercial Distribution
MEDSPIRA, LLC
Syringe, Luer-Locking, 100cc, 5-Pack
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
35053 | Manometric gastrointestinal motility analysis system |
An assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c8f8cbfe-0b2a-45e4-8d6d-83f7c75ff39b
December 30, 2024
1
December 20, 2024
December 30, 2024
1
December 20, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10851607003515 | 5 | 00851607003518 | In Commercial Distribution | bag |
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
[?]
612-789-0013
support@medspira.com
support@medspira.com