FDA UDI
In Commercial Distribution
🇺🇸 United States
Poolside Medical Rescue Refill
DI: M68924105050
·
Model: 05
·
Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Poolside Medical Rescue Refill
- Primary DI
- M68924105050
- Version / Model
- 05
- Catalog Number
- 24-105
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-14
- Public Version
- 1
- Public Version Date
- 2025-10-22
- Public Version Status
- New
- Public Device Record Key
- 611dc37d-bca5-4a74-84f5-ad1f6fbb7d9a
Device Description
Set provides medical support for bleeding control and wound care to facilitate injuries that may happen in or around pools, or areas of high humidity or moisture until further advanced care arrives.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LRR | First Aid Kit With Drug | Unknown | N |
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 | M68924105050 | HIBCC |
Customer Contacts
- Phone
- 855-428-6074
- [email protected]