FDA UDI
In Commercial Distribution
🇺🇸 United States
21G x 3/4 Safety Blood Collection 12" Tubing
DI: 00853620005401
·
Model: 023336262125
·
Merit Pharmaceutical
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- 21G x 3/4 Safety Blood Collection 12" Tubing
- Primary DI
- 00853620005401
- Version / Model
- 023336262125
- Company Name
- Merit Pharmaceutical
- Labeler DUNS
- 093370369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-01
- Public Version
- 3
- Public Version Date
- 2025-11-24
- Public Version Status
- Update
- Public Device Record Key
- 76b6d0d6-6ed0-4dbc-b9cc-bb6dbd85d00e
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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 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 | 20853620005405 | GS1 | 4 | In Commercial Distribution | ||
| Package | 10853620005408 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00853620005401 | GS1 |
Customer Contacts
- Phone
- (323) 227-4831
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163093 | 000 |