Microstream 009991
GUDID 10884521593305
Starter Kit Adult
ORIDION MEDICAL 1987 LTD.
Nasal oxygen cannula, carbon-dioxide-sampling| Primary Device ID | 10884521593305 |
| NIH Device Record Key | 3b38c98d-8fa6-43cf-be13-adbb225958e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microstream |
| Version Model Number | 009991 |
| Catalog Number | 009991 |
| Company DUNS | 600111512 |
| Company Name | ORIDION MEDICAL 1987 LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
| Special Storage Condition, Specify | Between 0 and 0 *none; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521593305 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K011536
FDA Product Code
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-03-22 |
| Device Publish Date | 2017-11-27 |
On-Brand Devices [Microstream]
| 10884521592469 | MICROSTREAM PAIN MANAGEMENT SAMPLE PAK |
| 10884521552425 | CapnoLine H O2 Adult CO2 Nasal Sampling Set with O2 Tubing for Long Term Use |
| 10884521552418 | FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adaptor for Humid Environments |
| 10884521552395 | VitaLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adaptor for High Ambient Humidity |
| 20884521552378 | SMART CAPNOLINE PLUS O2 LG ADU/INT 25UN M.ISRAEL |
| 20884521552361 | SMART CAPNOLINE GUARDIAN O2, 25 UN M.ISRAEL |
| 10884521552340 | FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter |
| 10884521552333 | SMART CAPNOLINE GUARDIAN O2 LG 25 UN M.ISRAEL |
| 10884521552319 | Smart CapnoLine Plus O2 Adult/Intermediate CO2 Oral/Nasal Sampling Set with O2 Tubing |
| 10884521552302 | MICROSTREAM SMART CAPNOLINE H PLUS O2 25 UN ORD M.ISRAEL |
| 10884521552296 | MICROSTREAM FILTERLINE H SET ADU/PED 25UN ORIDION M.ISRAEL |
| 10884521551916 | SMART CAP+ O2 LG ADU/INT (25) |
| 10884521531635 | MICROSTREAM ADULT ORAL-NASAL MICROSTREAM FILTERLINE O2 4M 25 |
| 10884521531604 | MICROSTREAM ADULT ORAL-NASAL MICROSTREAM FILTERLINE 2M 25UN |
| 10884521531567 | MICROSTREAM PEDIATRIC ORAL-NASAL MICROSTREAM FILTERLINE O2 2 |
| 10884521531550 | MICROSTREAM ADULT-PED BITE BLOCK MICROSTREAM FILTERLINE 02 2 |
| 30884521216017 | FTL H SET LONG INF/NEO 1 UN ORIDION |
| 10884521619340 | CARIL VITALINE INF/NEO SET 1UN |
| 20884521591698 | FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter |
| 10884521548404 | MICROSTREAM Capnostream35 External Charger |
| 10884521551497 | CAPNOSTREAM 20P (INTL) N - ROHS |
| 10884521551473 | CAPNOSTREAM 20P (INTL) N W/PRINTER |
| 10884521551466 | CAPNOSTREAM 20P (INTL) N |
| 10884521761216 | PM35MN-RR, with Microstream and Nellcor SPO2 Technologies, with Nellcor RR and SPD |
| 10884521551596 | Microstream XXXX |
| 10884521551589 | MICROSTREAM CAPNOSTREAM 35 PORTABLE RESPIRATORY MONITOR(EURO |
| 10884521591745 | CAPNOSTREAM 35 PORTABLE RESPIRATORY MONITOR-BRAZIL |
| 10884521551978 | 015183 |
| 10884521551503 | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS |
| 10884521551480 | CAPNOSTREAM 20P (US) N - ROHS |
| 10884521551398 | Microstream XXXX |
| 10884521807198 | CS78651 |
| 10884521592452 | MILITARY / AIR MEDICAL FL SAMPLEPAK |
| 10884521209213 | Used CS20P (US) N W/PRINTER, DS |
| 10884521591332 | MSM INTF KIT PKG |
| 10884521551510 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS |
| 10884521591226 | HANDHELD RECHARGEABLE BATTERY PACK |
| 10884521554115 | MICROSTREAM CAPNOLINE H INF/NEO LONG 1UN |
| 20884521551869 | CAPNOLINE H INF/NEO 1 UN ORI |
| 20884521551838 | NIV LINE PED 1 UN ORI |
| 10884521593312 | Starter Kit Pediatric |
| 10884521593305 | Starter Kit Adult |
| 20884521552408 | 015310 Microstream |
| 20884521552255 | Microstream XXXX |
| 30884521552146 | SMART CAPNOLINE GUARDIAN O2, 1 UN |
| 30884521552115 | SMART CAPNOLINE GUARDIAN O2 LONG, 1 UN |
| 20884521554136 | MICROSTREAM SMART CAPNOLINE GUARDIAN, 1 UN |
| 20884521552071 | Microstream XXXX |
| 20884521552064 | Microstream XXXX |
| 10884521554108 | SP00014977 |
Trademark Results [Microstream]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICROSTREAM 97852335 not registered Live/Pending |
Tech 387 LLC 2023-03-22 |
 MICROSTREAM 88437409 not registered Live/Pending |
Tally USA, LLC 2019-05-20 |
 MICROSTREAM 77079033 3415213 Live/Registered |
Streamlight, Inc. 2007-01-09 |
 MICROSTREAM 76132568 2687148 Live/Registered |
NORTH AMERICAN FILTER CORPORATION 2000-09-22 |
 MICROSTREAM 75801317 2383103 Live/Registered |
ORIDION MEDICAL 1987 LTD. 1999-09-16 |
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