FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Regard™
DI: 10194717120797
·
Model: HT00026N
·
ROI CPS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Regard™
- Primary DI
- 10194717120797
- Version / Model
- HT00026N
- Company Name
- ROI CPS, LLC
- Labeler DUNS
- 117174678
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-04
- Public Version
- 2
- Public Version Date
- 2025-06-06
- Public Version Status
- Update
- Public Device Record Key
- 9c026ea1-ddec-4235-97f4-dccb60748a8d
- Distribution End Date
- 2025-06-05
Device Description
ANGIOGRAPHY DRAPE KIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OEQ | Angiography/Angioplasty Kit | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16545 | Angiography kit | A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20194717120794 | GS1 | 3 | Not in Commercial Distribution | 2025-06-05 | |
| Primary | 10194717120797 | GS1 |