DEVICE: UltiCare (10357515193350)

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Device Record History
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Device Identifier (DI) Information
UltiCare
0335PL
In Commercial Distribution

ULTIMED, INC.
10357515193350
GS1

10
024723541 *Terms of Use
09335 .3cc 30G 1/2"
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
No
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?
38501 Insulin syringe/needle, basic
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMI Needle, Hypodermic, Single Lumen
FMF Syringe, Piston
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
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
4433dbe3-02dc-4423-b223-be2b3b4a547b
April 09, 2021
6
September 24, 2016
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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
20357515093350 10 10357515193350 In Commercial Distribution Box
20357515073352 10 10357515193350 In Commercial Distribution UltiGuard
20357515910039 9 10357515193350 In Commercial Distribution 90ct-Box
20357515181217 10 10357515193350 In Commercial Distribution Healthy Accents Box
20357515083351 10 10357515193350 In Commercial Distribution Health Wise Box
20357515123354 10 10357515193350 In Commercial Distribution UltiGuard
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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: 00357515193353 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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