DEVICE: SJM™ (05414734405331)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
37423 | Pin-indexed adaptor, reusable |
A connecting device intended to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZF | STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) |
GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K130545 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b05d556f-9130-479b-b3ae-b0e60a5e3e5a
July 06, 2018
3
April 15, 2015
July 06, 2018
3
April 15, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com