Invos
OxyAlert NIRSensor Cerebral/Somatic - Neonatal;For use with the INVOS (R) 5100C System technology
5manufacturers in China registered for this device type
54catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Sichuan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | MUD |
| Device type | Oximeter, Tissue Saturation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| 510(k) | K182868 |
| Record published | 2019-07-31 |
| Record revised | 2026-04-07 (version 16) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Keep dry; Storage environment humidity 10 to 95 % RH; Storage environment temperature -4 to 113 °F; Storage environment atmospheric pressure 47 to 108 KiloPascal |
| Packaging | Case of 8, case of 56, pack_or_inner_pack of 10, case of 10, pack_or_inner_pack of 5, case of 2 |
| Distribution end date | 2025-06-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PMAC71RSC | In distribution | |
| PMAC71DOC | Electric Potential,18-19,V; | In distribution |
| DL5100C-US | In distribution | |
| PMSENS71-P | Weight, range 4 to 40, kg; | In distribution |
| PMAC71RSC-L-CH1 | In distribution | |
| PMC71V-SF | In distribution | |
| SPFB/USA | Patient Weight,< 40,Kilogram; | In distribution |
| 5100C-PB-OEM | In distribution | |
| PMVAC-AFTD101P | In distribution | |
| 5100C-US | In distribution | |
| PMAC71RIC | In distribution | |
| SAFB-SM/INTL | Patient Weight,> 40,Kilogram; | In distribution |
| PMPAMP71 | In distribution | |
| CNN/SNN | Patient Weight, < 5,Kilogram; | In distribution |
| SPFB/INTL20 | Patient Weight,< 40,Kilogram; | In distribution |
| PM7100 | Electric Potential,18,V; | In distribution |
| PMC71V-GE | In distribution | |
| RSC-3 | In distribution | |
| PM7100 | In distribution | |
| PMSENS71-A | Patient weight, >40, KG; | In distribution |
| 5100C-PA | In distribution | |
| PMPAMP71 | In distribution | |
| 5100C-JP | In distribution | |
| SAFB-SM/INTL20 | Patient Weight,> 40,Kilogram; | In distribution |
| PMAC71DOC | In distribution | |
| PMSENS71-A | Patient weight, >40, KG; | In distribution |
| 5100C-PB | In distribution | |
| PMAC71RSC-L-CH3 | In distribution | |
| RSC-2 | In distribution | |
| DL5100C-PB | In distribution | |
| DLPMPAMP71 | In distribution | |
| SAFB-SM/USA | Patient Weight,> 40,Kilogram; | In distribution |
| SPFB/INTL | Patient Weight,< 40,Kilogram; | In distribution |
| CNN | Patient Weight,< 5,Kilogram; | In distribution |
| PMVAC-AFTD101A | In distribution | |
| SNN | Patient Weight,< 5,Kilogram; | In distribution |
| 5100C-EU | In distribution | |
| PMAC71RSC-L-CH4 | In distribution | |
| IS | Patient Weight, < 40, kg; | In distribution |
| CNN/SNN | Weight, less than 5, kg; | In distribution |
| PM7100 | In distribution | |
| PMC71VP-GE | In distribution | |
| IS | Patient Weight, less than 40, kg only; | In distribution |
| 5100C-PA-OEM | In distribution | |
| PMPAMP71 | In distribution | |
| DL5100C-PA | In distribution | |
| RSC-4 | In distribution | |
| PMAC71RSC-L-CH2 | In distribution | |
| RSC-1 | In distribution | |
| DS5100C-PB | Withdrawn | |
| DS5100C-PA | Withdrawn | |
| DS5100C-US | Withdrawn | |
| IS-S | Patient Weight; < 40 kg; | Withdrawn |
| IS-C | Patient Weight, < 40, kg; | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nonin | Nonin Medical, Inc. | 30 |
| Fore-Sight Elite® | Cas Medical Systems, Inc. | 12 |
| Fore-Sight® | Cas Medical Systems, Inc. | 9 |
| ForeSight | Edwards Lifesciences Technology Sarl | 7 |
| Spectros T-Stat | Spectros Corporation | 7 |
| Component Neuromonitoring System | Moberg Research, Inc. | 6 |
| HyperView | Hypermed Imaging, Inc. | 6 |
| O3 | Masimo Corporation | 5 |
| Mespere | Mespere Lifesciences Inc. | 3 |
| SnapshotNIR | Kent Imaging Inc | 2 |
| Moor Instruments Ltd | Moor Instruments Ltd. | 2 |
| T.Ox SS Sensor | Vioptix, Inc. | 1 |
Showing 12 of 30. All products under Oximeter, Tissue Saturation
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2024-01-09 | Class II | Process design | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel | 1122 units |
| Covidien | 510(k) number | 2024-01-09 | Class II | Process design | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel | 2305 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.