FDA UDI
In Commercial Distribution
🇺🇸 United States
Green Guard Small Burn Kit
DI: 00347682011970
·
Model: 1197
·
Greenguard
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Green Guard Small Burn Kit
- Primary DI
- 00347682011970
- Version / Model
- 1197
- Catalog Number
- 1197
- Company Name
- Greenguard
- Labeler DUNS
- 176528040
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-15
- Public Version
- 2
- Public Version Date
- 2019-09-10
- Public Version Status
- Update
- Public Device Record Key
- eacbe860-6b59-43f5-bf66-2709584dea9d
Device Description
1139 -1.000 EACH 10 Unit Kit Empty Plastic 3160 -2.000 EACH WJ Burn Dressing 4x4 7920 -1.000 EACH Glove Wipes 20669 -1.000 EACH Burn Cream w/Lidocaine Unit (1 3002 -1.000 EACH GG Derma Cool (2 oz.) 6117 -1.000 EACH 3" Sterile Gauze Roll 9010B -1.000 EACH Burn Relief Kit Stickers 6253 -1.000 EACH Waterproof Tape 1/2" x 5yds 6205 -1.000 EACH GG 3x3 Gauze Pads (10)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| OJI | Burn Kit With Drug | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10516 | Burn kit, non-medicated | A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50347682011975 | GS1 | master case | 1 | In Commercial Distribution | |
| Primary | 00347682011970 | GS1 |
Customer Contacts
- Phone
- 1-800-869-6970
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature.