FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00815277020800
·
Model: 301-0723ANEVALPACK
·
BOUND TREE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00815277020800
- Version / Model
- 301-0723ANEVALPACK
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 81bbda3a-73a8-4453-9b06-237365bf41aa
Device Description
*For THS Only * Curaplex Aneclear For Eval Only - Ths 5/Pk
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| CBN | APPARATUS, GAS-SCAVENGING | Anesthesiology | 868.5430 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36696 | Anaesthetic gas scavenging unit | A device intended to collect excess anaesthetic, analgesic, or trace gases or vapours from a patient's breathing system, ventilator, or extracorporeal oxygenator, and to expel them by means of an exhaust system. Some types may be connected to a special mixing box for the removal of orthopaedic bone cement gases. This device is an independent unit and may be used in association with various kinds of devices and systems. This device is also known as an anaesthetic gas scavenging system (AGSS). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815277020800 | GS1 |