DEVICE: Spectra (08809108013026)
Device Identifier (DI) Information
Spectra
Spectra accessory(24mm Breast shield)
In Commercial Distribution
UZINMEDICARE CO.,LTD
Spectra accessory(24mm Breast shield)
In Commercial Distribution
UZINMEDICARE CO.,LTD
This is a funnel shaped accessory, which come in contact with breat to express milk.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
61734 | Breast pump support kit, reusable |
A collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HGX | Pump, Breast, Powered |
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 |
---|
Lumen/Inner Diameter: 24 Millimeter |
Device Record Status
5098749e-691c-4fc3-a7e9-30f964ea7386
March 17, 2021
3
March 23, 2018
March 17, 2021
3
March 23, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
28809108013143 | 40 | 08809108013026 | In Commercial Distribution | Carton box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
08809108012784
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+821053081195
shahn@uzinmedical.co.kr
shahn@uzinmedical.co.kr