DEVICE: NA (00840682102872)
Device Identifier (DI) Information
NA
D-lite Spirometry Kit 2m 7ft, 8004381
In Commercial Distribution
GE Healthcare Finland Oy
D-lite Spirometry Kit 2m 7ft, 8004381
In Commercial Distribution
GE Healthcare Finland Oy
D-LITE+ SPIROMETRY KIT 2 M/7 FT, 8004381
Device Characteristics
| MR Unsafe | |
| No | |
| No | |
| Yes | |
| No | |
| 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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| BZL | COMPUTER, OXYGEN-UPTAKE |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| BZK | Spirometer, monitoring (w/wo alarm) |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
9a613d2d-6642-47ca-8a2c-dccfa5760022
August 05, 2022
8
August 15, 2016
August 05, 2022
8
August 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 20840682102876 | 20 | 00840682102872 | In Commercial Distribution |
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
[?]
+1(800)558-5120
xx@xx.xx
xx@xx.xx