DEVICE: Gel Warmer Kit(with Left Rack) (06944904089805)

Device Identifier (DI) Information

Gel Warmer Kit(with Left Rack)
115-037333-00
In Commercial Distribution

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
06944904089805
GS1

1
654671304 *Terms of Use
No description.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Gel warmer A portable, mains electricity (AC-powered) device intended to be used to prewarm gels (e.g., ultrasonic coupling gels, vaginal exploratory gels) prior to patient application. It is typically a tabletop device that includes a recess or a well for placement of a gel container, a heating element, a thermostat, and operating controls.
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FDA Product Code

[?]
Product Code Product Code Name
IYN System, imaging, pulsed doppler, ultrasonic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K162267 000
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

799e7ece-0c37-4f28-8a72-9731885d041b
July 06, 2018
3
September 23, 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
No Package DIs found
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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+8675581888998
service@mindray.com.cn
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