DEVICE: PF 1010 Straight Silicone Rubber Connector (M996PF10100)
Device Identifier (DI) Information
PF 1010 Straight Silicone Rubber Connector
PF 1010
In Commercial Distribution
PF 1010
INSTRUMENTATION INDUSTRIES, INCORPORATED
PF 1010
In Commercial Distribution
PF 1010
INSTRUMENTATION INDUSTRIES, INCORPORATED
Straight Connector - 10mm ID x 10mm ID. Fits components of neonatal ventilator circuits. Molded of silicone rubber. Reusable.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
42601 | Straight/elbow breathing circuit connector, reusable |
A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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Ethylene Oxide |
High-level Disinfectant |
Radiation Sterilization |
Moist Heat or Steam 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
b4159384-796a-405c-9445-85ab3900d716
November 28, 2022
2
September 10, 2021
November 28, 2022
2
September 10, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M996PF10102 | 10 | M996PF10100 | In Commercial Distribution | Ziplock Bag | |
M996PF10105 | 50 | M996PF10100 | In Commercial Distribution | Ziplock Bag |
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
[?]
412-854-1133
raqa@iiimedical.com
raqa@iiimedical.com