Microstream PM35MN02-RR
GUDID 10884521761216
PM35MN-RR, with Microstream and Nellcor SPO2 Technologies, with Nellcor RR and SPD
ORIDION MEDICAL 1987 LTD.
Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor| Primary Device ID | 10884521761216 |
| NIH Device Record Key | f0d20681-9d78-4f97-b850-592c0d7cabe6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microstream |
| Version Model Number | PM35MN02-RR |
| Catalog Number | PM35MN02-RR |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521761216 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200594
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-21 |
| Device Publish Date | 2020-09-11 |
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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