DEVICE: GaleMed (04710810082030)

Device Identifier (DI) Information

GaleMed
70062
In Commercial Distribution

GaleMed Xiamen Co., Ltd.
04710810082030
GS1

100
527333326 *Terms of Use
Disposable Tube Clip 22mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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
Universal patient tubing holder, non-sterile A small, non-sterile device with a locking/holding mechanism designed to secure tubing or tubing-like devices (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. It is not designed to hold a specific type or brand of tubing. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.
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FDA Product Code

[?]
Product Code Product Code Name
JAY Support, Breathing Tube
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

55c43297-83f1-4ec9-925b-05680fb465ce
March 29, 2018
2
September 19, 2015
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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
44710810082038 20 04710810082030 In Commercial Distribution Carton
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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: 94710810082033 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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