FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00840682103664
·
Model: D-lite Spirometry Kit, 3m/10ft
·
GE Healthcare Finland Oy
Product Codes
10
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00840682103664
- Version / Model
- D-lite Spirometry Kit, 3m/10ft
- Company Name
- GE Healthcare Finland Oy
- Labeler DUNS
- 401966697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 5
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- cfab1367-bb49-4722-b57b-2518691bea93
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | Anesthesiology | 868.2600 | 2 |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) | Anesthesiology | 868.1700 | 2 |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) | Anesthesiology | 868.1500 | 2 |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) | Anesthesiology | 868.1500 | 2 |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE | Anesthesiology | 868.1720 | 2 |
| BZK | Spirometer, monitoring (w/wo alarm) | Anesthesiology | 868.1850 | 2 |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) | Anesthesiology | 868.1500 | 2 |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) | Anesthesiology | 868.1620 | 2 |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) | Anesthesiology | 868.1500 | 2 |
| BZL | COMPUTER, OXYGEN-UPTAKE | Anesthesiology | 868.1730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20840682103668 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00840682103664 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051092 | 000 |