DEVICE: CFM Technologies (00850013958153)

Device Identifier (DI) Information

CFM Technologies
ENT-LS
In Commercial Distribution

C F M TECHNOLOGIES INC
00850013958153
GS1

1
040748944 *Terms of Use
Special Operation Laryngoscope Set.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
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?
46828 Laryngoscope blade, single-use
The segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.
Active false
46830 Laryngoscope handle, reusable
The hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a reusable device.
Active false
60381 Laryngoscope light-emitting cell
A non-sterile, portable, battery-powered device intended to provide the light source for a laryngoscope (i.e., rigid intubation type) when fitted into the laryngoscope handle. It typically consists of a removable cylindrical cell that produces light which is emitted from the laryngoscope handle via a fibreoptic laryngoscope blade for airway illumination. The device may be kinetically or electrically recharged. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CCW Laryngoscope, Rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

1939d8f6-38ef-49c2-b403-3a8effbd591a
January 14, 2020
1
January 06, 2020
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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
No Package DIs found
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Secondary DI

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

[?]
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
No
No
No CLOSE

Customer Contact

[?]
6039243751
cfm@cfmtechnologies.com
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