FDA UDI
In Commercial Distribution
🇺🇸 United States
GE Healthcare Airway Gas Sampling Set
DI: 24251679601528
·
Model: Infant, 2m/7ft
·
BluePoint Medical GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
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Basic Information
- Brand Name
- GE Healthcare Airway Gas Sampling Set
- Primary DI
- 24251679601528
- Version / Model
- Infant, 2m/7ft
- Catalog Number
- 8090121522
- Company Name
- BluePoint Medical GmbH & Co. KG
- Labeler DUNS
- 507261522
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-02-20
- Public Version
- 2
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- ded6da69-69e5-41f8-870e-72bac19aa035
Device Description
Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.
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
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 04251679601524 | GS1 | ||||
| Primary | 24251679601528 | GS1 | ||||
| Secondary | EBPM8090121522 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 495 – 795 Millimeter of Mercury
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity