FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00810071631696
·
Model: 5707F-SE
·
BOUND TREE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00810071631696
- Version / Model
- 5707F-SE
- Catalog Number
- 301-5707F-SE
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-09-30
- Public Version
- 2
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- 69f89416-bcae-49b9-a42d-ffb420dc653f
Device Description
ADULT ORAL-NASAL 7FT ETCO2 FITS-ALL REFLECTIVE CONNECTOR
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
- Yes
- 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 |
|---|---|---|---|---|
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36306 | Nasal oxygen cannula, carbon-dioxide-sampling | A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810071631627 | GS1 | ||||
| Primary | 00810071631696 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063813 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7 | Feet | |
| Device Size Text, specify | ADULT ORAL-NASAL 7FT ETCO2 FITS-ALL REFLECTIVE CONNECTOR |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- General Warehouse