FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Critikon
DI: 10817357020394
·
Model: 2140
·
HYGIA HEALTH SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Critikon
- Primary DI
- 10817357020394
- Version / Model
- 2140
- Company Name
- HYGIA HEALTH SERVICES, INC.
- Labeler DUNS
- 177939027
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-28
- Public Version
- 4
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- 903c0add-c3db-46ce-bee5-29f1888fa9fd
- Distribution End Date
- 2019-02-21
Device Description
Critikon Soft Cuf One Tube Bayonet, Adult Long
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
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NPP | Reprocessed Blood Pressure Cuff | Cardiovascular | 870.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61801 | Blood pressure cuff, reprocessed | A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) intended to be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30817357020398 | GS1 | Box | 20 | Not in Commercial Distribution | 2021-03-19 |
| Primary | 10817357020394 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032821 | 000 |