FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HCS
DI: 00849027004635
·
Model: HCS9201-1000
·
DYAD MEDICAL SOURCING, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- HCS
- Primary DI
- 00849027004635
- Version / Model
- HCS9201-1000
- 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
- 2020-05-29
- Public Version
- 3
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- a6a61758-49a3-4825-a86d-b76da3d56ee1
- Distribution End Date
- 2020-08-01
Device Description
Pressure Infuser Cuff, 1000mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | General Hospital | 880.5420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13100 | Intravenous pressure infusor, manual, reusable | A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10849027004632 | GS1 | case | 30 | Not in Commercial Distribution | 2020-08-01 |
| Primary | 00849027004635 | GS1 |