DEVICE: Forsure (00815123011938)

Device Identifier (DI) Information

Forsure
11210060
In Commercial Distribution
11210060
FORSURE MEDICAL PRODUCTS LLC
00815123011938
GS1

1
033809722 *Terms of Use
A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
46967 Basic endotracheal tube, single-use
A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BTR Tube, Tracheal (W/Wo Connector)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042683 000
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: KEEP AWAY FROM HIGH TEMPERATURE AND HIGH HUMIDITY
Special Storage Condition, Specify: DO NOT STORE IN DIRECT SUNLIGHT
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 24 Fr
Lumen/Inner Diameter: 6.0 Millimeter
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Device Record Status

b819eebc-04c0-4727-97e4-199849e1acd9
June 19, 2020
4
October 25, 2017
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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
20815123011932 100 10815123011935 In Commercial Distribution MASTER CASE
10815123011935 10 00815123011938 In Commercial Distribution INNER BOX
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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