FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00812277031485
·
Model: 1431-55000
·
BOUND TREE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00812277031485
- Version / Model
- 1431-55000
- Catalog Number
- 1431-55000
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-15
- Public Version
- 1
- Public Version Date
- 2019-01-15
- Public Version Status
- New
- Public Device Record Key
- 0d932592-ac1f-4061-80b0-d59c6a8dbff2
Device Description
Curaplex Cold Pack - Small - 5" x 5"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IMD | PACK, HOT OR COLD, DISPOSABLE | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13755 | Mechanical stethoscope | A mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00812277031492 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 00812277031485 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 5 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- protect device from freezing
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 94 Degrees Fahrenheit