DEVICE: SYRINGE RETRACT U100 1cc 29x.5 (00369771003109)

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Device Record History
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Device Identifier (DI) Information
SYRINGE RETRACT U100 1cc 29x.5
11-444
In Commercial Distribution

GERI-GENTLE CORPORATION
00369771003109
GS1

1
361663839 *Terms of Use
SYRINGE RETRACT U100 1cc 29x.5
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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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?
59040 ENFit oral/enteral syringe, single-use
A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MEG Syringe, Antistick
FMF Syringe, Piston
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K210216 000
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
ece90b33-a473-4311-8e9b-79d2af231b9e
July 10, 2023
1
July 01, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00369771003123 100 00369771003109 In Commercial Distribution Inner
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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