FDA UDI
In Commercial Distribution
🇺🇸 United States
JosNoe Medical Inc
DI: 00850003294278
·
Model: JNM-200016
·
JOSNOE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- JosNoe Medical Inc
- Primary DI
- 00850003294278
- Version / Model
- JNM-200016
- Company Name
- JOSNOE MEDICAL, INC.
- Labeler DUNS
- 965627859
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-05
- Public Version
- 1
- Public Version Date
- 2019-11-13
- Public Version Status
- New
- Public Device Record Key
- 7250709a-014f-41b1-8dab-92a2e64de8c1
Device Description
Dual Chamber Scope Warmer that Pre-Warms Multiple Laparoscopes.
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NWV | Laparoscopic Accessories, Gynecologic | Obstetrics/Gynecology | 884.1720 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63518 | Instrument warmer, exothermic chemical | A sterile heating device intended to warm patient-contact instruments (e.g., rigid endoscopes or trocars) before they are introduced into body orifices or other parts of the body. It typically consists of an envelope that is wrapped around the instrument (e.g., laparoscope), and filled with a material which produces an exothermic chemical reaction when activated. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850003294285 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00850003294278 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 28 – Degrees Fahrenheit