FDA UDI
In Commercial Distribution
🇺🇸 United States
Marketlab Inc
DI: 00817517020540
·
Model: 5689
·
MARKETLAB INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Marketlab Inc
- Primary DI
- 00817517020540
- Version / Model
- 5689
- Catalog Number
- 5689
- Company Name
- MARKETLAB INC.
- Labeler DUNS
- 848917027
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 2
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 159d1a9d-c55d-4067-bd40-a3b72e2ccf6d
Device Description
Saf-T Holder w/Female Luer-50/pk.
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58147 | Blood collection tube spike syringe adaptor | A syringe transfer device or Luer-system adaptor intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from the blood access device (e.g., blood collection tube holder with needle) into a syringe that utilizes a Luer fitting (e.g., a blood gas syringe). The adaptor is intended to attach to both the blood access device and the syringe, allowing for syringe connection to an otherwise incompatible blood access device; this may reduce the number of venipunctures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817517020540 | GS1 | ||||
| Unit of Use | 00817517021325 | GS1 |
Customer Contacts
- Phone
- +1(866) 237-3722
- [email protected]