DEVICE: easypod (04054839025860)

Device Identifier (DI) Information

easypod
U1222102
In Commercial Distribution

EMD SERONO, INC.
04054839025860
GS1

1
088514898 *Terms of Use
easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cartridge-accepting autoinjector, electronic A portable, hand-held, battery-powered device designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and is replaced once the pharmaceutical is exhausted; the needle is replaced for each administration. The device includes an electronic display and may be capable of a variety of dose-recording functions. This is a reusable device.
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FDA Product Code

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No Product Codes
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FDA Premarket Submission

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Premarket Submission Number Not Available/Not Released
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Sterilization

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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

f2f61da2-e974-44f3-a071-745c07c68b40
April 19, 2019
1
April 11, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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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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None
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Production Identifier(s) in UDI

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Customer Contact

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1-877-447-3243
xx@xx.xx
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