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
00851607003518
GS1

1
962187964 *Terms of Use
Syringe, Luer-Locking, 100cc, 5-Pack
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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
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FDA Product Code

[?]
Product Code Product Code Name
KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c8f8cbfe-0b2a-45e4-8d6d-83f7c75ff39b
December 30, 2024
1
December 20, 2024
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
612-789-0013
support@medspira.com
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