FDA UDI
In Commercial Distribution
🇺🇸 United States
EMPACT 6+ Patient Hard Case Trauma Kit- Bat Flashlight RX
DI: B283E6HCXPD0
·
Model: B283EGHCXPD0
·
Pro1tek
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EMPACT 6+ Patient Hard Case Trauma Kit- Bat Flashlight RX
- Primary DI
- B283E6HCXPD0
- Version / Model
- B283EGHCXPD0
- Company Name
- Pro1tek
- Labeler DUNS
- 827067880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-23
- Public Version
- 1
- Public Version Date
- 2022-03-31
- Public Version Status
- New
- Public Device Record Key
- a1312074-2037-43f5-9c13-c2dffa1983a5
Device Description
EMAPCT 6+ Patient Hard Case Trauma Kit with Bat Flashlight- RX- Tactical & Medical Trauma Kit. Tactical side has Bat Flashlight, TAC-WEGE, TAC-KEYS and other Tactical components that can be used in an active shooter RUN, HIDE, FIGHT situation. Medical side has Bleeding Control Kits featuring extra hemostatic dressing and other Trauma First-Aid equipment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OVR | Kit, First Aid, Talking | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44039 | First aid kit, medicated | A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B283E6HCXPD0 | HIBCC |