DEVICE: NA (00840682138161)

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Device Record History
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Device Identifier (DI) Information
NA
D-LITE PATIENT SPIROMETRY SET 2104297-001
In Commercial Distribution

GE Healthcare Finland Oy
00840682138161
GS1

1
401966697 *Terms of Use
D-LITE++ PATIENT SPIROMETRY SET, 2M/7FT, 1 PCS
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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?
45566 Gas-sampling/monitoring respiratory tubing, single-use
A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAP MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
CBR ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
BZL COMPUTER, OXYGEN-UPTAKE
NHP Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
CCL ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
CBS ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)
NHO Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
NHQ Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)
CBQ ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
BZK Spirometer, monitoring (w/wo alarm)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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
87eade2c-0071-4c3f-8fe9-99fdbd9dae4f
April 29, 2025
7
June 19, 2019
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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
00840682138246 20 00840682138161 In Commercial Distribution Box
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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

[?]
No Customer Contact currently defined
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