DEVICE: Babi.Plus (04710810100796)
Device Identifier (DI) Information
Babi.Plus
BC01-HD
In Commercial Distribution
Bubble PAP Valve 0-10cmH2O
GALEMED CORPORATION
BC01-HD
In Commercial Distribution
Bubble PAP Valve 0-10cmH2O
GALEMED CORPORATION
Distributed by Teleflex
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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14337 | PEEP valve, reusable |
A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BYE | Attachment, Breathing, Positive End Expiratory Pressure |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K090317 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3eab8646-870d-47bc-807a-60b642c4f5e6
July 06, 2018
3
September 24, 2015
July 06, 2018
3
September 24, 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 |
---|---|---|---|---|---|
44710810100794 | 2 | 24710810100790 | In Commercial Distribution | Carton | |
24710810100790 | 12 | 04710810100796 | In Commercial Distribution | Box |
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