FDA UDI
In Commercial Distribution
🇺🇸 United States
Masimo
DI: 00816317023492
·
Model: RM-2321
·
RENU MEDICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Masimo
- Primary DI
- 00816317023492
- Version / Model
- RM-2321
- Company Name
- RENU MEDICAL, INC
- Labeler DUNS
- 100439103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-29
- Public Version
- 2
- Public Version Date
- 2023-09-08
- Public Version Status
- Update
- Public Device Record Key
- b31e66ea-7811-4c6c-b8cc-4c88b8ccd0f6
Device Description
LNCS Neonatal/Adult Probe-L 2321
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NLF | Oximeter, Reprocessed | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36087 | Pulse oximeter probe, reprocessed | A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816317023499 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00816317023492 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081927 | 000 |