FDA UDI
In Commercial Distribution
🇺🇸 United States
Microstream
DI: 20884521551982
·
Model: 015328
·
ORIDION MEDICAL 1987 LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Microstream
- Primary DI
- 20884521551982
- Version / Model
- 015328
- Company Name
- ORIDION MEDICAL 1987 LTD.
- Labeler DUNS
- 600111512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 11
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 150efa4d-5b39-42d7-a3f2-5cb1f7d8e1f2
Device Description
FILTERLINE SET ADULT/PEDIATRIC 1 UN
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 Safe
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10884521551985 | GS1 | CASE | 4 | In Commercial Distribution | |
| Package | 30884521551989 | GS1 | PACK_OR_INNER_PACK | 25 | In Commercial Distribution | |
| Primary | 20884521551982 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]