DEVICE: NA (07613327175172)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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15732 | Birthing bed/table, powered |
An electrically-powered, adjustable device designed to support a pregnant woman's body in an appropriate position during labour and delivery, and may in addition be intended for other obstetrical examination or treatment procedures. This device may be referred to as a birthing/obstetric bed, table, couch, or chair, and will typically include, leg holders (stirrups), traction handles, a receptacle for afterbirth, and have facilities for the attachment of different accessories.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HDD | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K950889 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 500 and 1060 KiloPascal |
Storage Environment Atmospheric Pressure: between 500 and 1060 KiloPascal |
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between -4 and 104 Degrees Fahrenheit |
Handling Environment Temperature: between -4 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bb102ee7-4a9f-4519-813b-2d68596dc0af
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined