FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HCS
DI: 00849027002174
·
Model: HCS0008B
·
DYAD MEDICAL SOURCING, LLC
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HCS
- Primary DI
- 00849027002174
- Version / Model
- HCS0008B
- Company Name
- DYAD MEDICAL SOURCING, LLC
- Labeler DUNS
- 078572603
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-13
- Public Version
- 5
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 317c88f3-35e7-4faa-8d36-817fccf339a1
- Distribution End Date
- 2020-03-27
Device Description
PICC Line Advanced Dressing Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34059 | Wound dressing kit, medicated | A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10849027002171 | GS1 | Case | 30 | Not in Commercial Distribution | 2020-03-27 |
| Primary | 00849027002174 | GS1 |