FDA UDI
In Commercial Distribution
🇺🇸 United States
DISP NK COMP SPO2 SNSR,TL-272T3,PDTRC,63",CLR FLM,NON-STRL,EACH
DI: 00840828186018
·
Model: CSA027DP-P200
·
CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DISP NK COMP SPO2 SNSR,TL-272T3,PDTRC,63",CLR FLM,NON-STRL,EACH
- Primary DI
- 00840828186018
- Version / Model
- CSA027DP-P200
- Catalog Number
- 28177
- Company Name
- CURBELL MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 796452311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-28
- Public Version
- 3
- Public Version Date
- 2024-05-27
- Public Version Status
- Update
- Public Device Record Key
- c5bd1caa-761d-478a-923f-66622745ab1d
Device Description
DISP NK COMP SPO2 SNSR,TL-272T3,PDTRC,63",CLR FLM,NON-STRL,EACH
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
- No
- 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 |
|---|---|---|---|---|
| 31658 | Pulse oximeter probe, single-use | 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. The is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840828186015 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00840828186018 | GS1 |
Customer Contacts
- Phone
- 1-800-235-7500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103685 | 000 |