FDA UDI
In Commercial Distribution
🇺🇸 United States
Rospital Productos Medicos
DI: 00812460027899
·
Model: RBC23
·
ATLAS MEDICAL PRODUCTS LLC
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Rospital Productos Medicos
- Primary DI
- 00812460027899
- Version / Model
- RBC23
- Catalog Number
- RBC23
- Company Name
- ATLAS MEDICAL PRODUCTS LLC
- Labeler DUNS
- 013112308
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-29
- Public Version
- 3
- Public Version Date
- 2022-02-23
- Public Version Status
- Update
- Public Device Record Key
- fbee4e99-a66a-4235-bcdd-51cf685be24f
Device Description
NON-SAFETY (REGULAR) BLOOD COLLECTION SET 23G X 3/4", Each
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
| KST | System, Blood Collection, Vacuum-Assisted, Manual | Hematology | 864.9125 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10812460027896 | GS1 | INNER BOX | 100 | In Commercial Distribution | |
| Primary | 00812460027899 | GS1 | ||||
| Package | 20812460027893 | GS1 | CASE | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 7864739436
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000369 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | NON-SAFETY (REGULAR) BLOOD COLLECTION SET 23G X 3/4", Each |