FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDALink
DI: G096MNKS2SADT0
·
Model: M-NK-S2S-ADT
·
Rising Eagle Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MEDALink
- Primary DI
- G096MNKS2SADT0
- Version / Model
- M-NK-S2S-ADT
- Catalog Number
- M-NK-S2S-ADT
- Company Name
- Rising Eagle Medical LLC
- Labeler DUNS
- 080145608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-08
- Public Version
- 1
- Public Version Date
- 2023-11-16
- Public Version Status
- New
- Public Device Record Key
- 0f981ae0-4842-4c78-992e-170116ec0d71
Device Description
Nihon Kohden Compatible Disposable SpO2 Sensor, Adult, 50pcs/box
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
- Yes
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47581 | Pulse Co-oximeter probe, single-use | A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | G096MNKS2SADT5 | HIBCC | Box | 50 | In Commercial Distribution | |
| Primary | G096MNKS2SADT0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172981 | 000 |