FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Exel SecureTouch Safety Blood Collection Set
DI: 10020221277644
·
Model: 27764
·
Exel International
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Exel SecureTouch Safety Blood Collection Set
- Primary DI
- 10020221277644
- Version / Model
- 27764
- Catalog Number
- 27764
- Company Name
- Exel International
- Labeler DUNS
- 180572216
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2023-04-24
- Public Version Status
- Update
- Public Device Record Key
- 08d1c40d-fd25-487a-a36f-ed33714ea4ed
- Distribution End Date
- 2023-04-21
Device Description
Safety Scalp Vein Set/Multi-Sample Luer Adapter, 21G X 3/4, 12" tube
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
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60579 | Luer-ended blood collection tube spike | A device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20020221277641 | GS1 | 4 | Not in Commercial Distribution | 2023-04-21 | |
| Primary | 10020221277644 | GS1 | ||||
| Unit of Use | 00020221277647 | GS1 |