FDA UDI
In Commercial Distribution
🇺🇸 United States
EXEL SAFETY PSV SET 23G X 3/4", 12" TUBE
DI: 00020221278064
·
Model: 27806
·
Exel International
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- EXEL SAFETY PSV SET 23G X 3/4", 12" TUBE
- Primary DI
- 00020221278064
- Version / Model
- 27806
- Catalog Number
- 27806
- Company Name
- Exel International
- Labeler DUNS
- 180572216
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-17
- Public Version
- 1
- Public Version Date
- 2023-03-27
- Public Version Status
- New
- Public Device Record Key
- 6d1b712f-43cf-42c4-8c0e-dc7bed72565d
Device Description
EXEL SAFETY PSV SET 23G X 3/4", 12" TUBE, 50/BX, 500/CS
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
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | 880.5200 | 2 |
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 | 10020221278061 | GS1 | Inner box | 50 | In Commercial Distribution | |
| Primary | 00020221278064 | GS1 | ||||
| Package | 20020221278068 | GS1 | Outer box | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010197 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius