FDA UDI
In Commercial Distribution
🇺🇸 United States
Personal Device Holder
DI: 00848530086992
·
Model: CSBML6-Hardshell
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Personal Device Holder
- Primary DI
- 00848530086992
- Version / Model
- CSBML6-Hardshell
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-28
- Public Version
- 2
- Public Version Date
- 2024-09-19
- Public Version Status
- Update
- Public Device Record Key
- 8cd0e6c3-9705-4657-ab64-a6bcb31fe747
Device Description
Hardshell Bag for ML6 HomeFill Tanks
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37685 | Personal device holder, reusable | A portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, headband, or clothing, or as a trolley with wheels. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530086992 | GS1 |
Customer Contacts
- Phone
- 8775786738
- [email protected]