FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00815277021586
·
Model: 670064-KIT
·
BOUND TREE MEDICAL, LLC
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00815277021586
- Version / Model
- 670064-KIT
- Catalog Number
- 670064-KIT
- 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
- 4
- Public Version Date
- 2022-08-16
- Public Version Status
- Update
- Public Device Record Key
- ae1a3805-8165-4aad-b2c2-ea062c999169
Device Description
Curaplex IV Start Kit w/Tegaderm, 8 in Ext Set, 10ml Flush Syr, 2x2 Gauze, Alcohol Prep, TQ, Tape
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|
| LRS | I.V. start kit | General Hospital | 880.5200 | 2 |
| POQ | Blood transfusion kit | General Hospital | 880.5440 | 2 |
| FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33963 | Peripheral intravenous catheterization support kit | A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815277021586 | GS1 | ||||
| Package | 00810094570736 | GS1 | CS | 50 | In Commercial Distribution |