FDA UDI
In Commercial Distribution
🇺🇸 United States
SampLok® System with Hinged Lid
DI: 19555240400045
·
Model: A100648
·
ITL ASIA PACIFIC SDN. BHD.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
700
Basic Information
- Brand Name
- SampLok® System with Hinged Lid
- Primary DI
- 19555240400045
- Version / Model
- A100648
- Catalog Number
- A100648
- Company Name
- ITL ASIA PACIFIC SDN. BHD.
- Labeler DUNS
- 597723837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 700
- Record Status
- Published
- Publish Date
- 2019-05-23
- Public Version
- 1
- Public Version Date
- 2019-05-31
- Public Version Status
- New
- Public Device Record Key
- 3b8320a2-fe1a-43cd-808c-0fcbc5e298e7
Device Description
SampLok® Hinged Lid (Wide Bore), Clear, Assembled with PC Luer with Isoprene Sleeve, Bulk, Non-Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37566 | Blood collection tube holder, single-use | A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 19555240400045 | GS1 | ||||
| Unit of Use | 09555240400048 | GS1 |
Customer Contacts
- Phone
- +18884112851
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Direct Sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry