FDA UDI
In Commercial Distribution
🇺🇸 United States
HCS
DI: 00810132041723
·
Model: HCS9026
·
Concordance Healthcare Solutions LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HCS
- Primary DI
- 00810132041723
- Version / Model
- HCS9026
- Company Name
- Concordance Healthcare Solutions LLC
- Labeler DUNS
- 080220245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-28
- Public Version
- 1
- Public Version Date
- 2023-08-07
- Public Version Status
- New
- Public Device Record Key
- 69627c4a-3565-4f99-970b-2d9b02f36b3a
Device Description
Bulb and Valve Assembly
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42398 | Blood pressure cuff inflator, manual | A bulb-like device intended to be used to manually inflate the cuff of a manual sphygmomanometer. It is connected to one of the connectors of the cuff and the operator manually pumps air into the cuff by continually squeezing this device until the desired pressure within the cuff has been reached. It will typically consist of a rubber bulb, a one-way valve that draws in ambient air, and a release valve used by the operator to slowly release the pressure in the complete sphygmomanometer/cuff/inflator system so that blood pressure can be measured. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810132041720 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00810132041723 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942543 | 000 |