FDA UDI
In Commercial Distribution
🇺🇸 United States
Segment Sampler (SEG)
DI: 19555240401332
·
Model: A200200
·
ITL ASIA PACIFIC SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Segment Sampler (SEG)
- Primary DI
- 19555240401332
- Version / Model
- A200200
- Catalog Number
- A200200
- Company Name
- ITL ASIA PACIFIC SDN. BHD.
- Labeler DUNS
- 597723837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-19
- Public Version
- 1
- Public Version Date
- 2020-09-28
- Public Version Status
- New
- Public Device Record Key
- 2a6159a5-7a4a-4ea8-ab8f-0fd01b1b9665
Device Description
SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
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
- Yes
- 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 |
|---|---|---|---|---|
| KSS | Supplies, Blood-Bank | Hematology | 864.9050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60210 | Blood donor bag segment sampling IVD | A sampling device intended to be used for extracting a blood specimen from a blood donor bag tubing segment for analysis and/or other investigation (e.g., blood grouping, cross matching). It typically consists of a needle surrounded by plastic housing designed so that the blood-filled tubing segment may be inserted into the housing, pierced by the needle, and a sample manually extracted without exposing the user to either the blood or 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 | 19555240401349 | GS1 | Inner Box | 60 | In Commercial Distribution | |
| Primary | 19555240401332 | GS1 | ||||
| Package | 19555240401356 | GS1 | Carton | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +18884112851
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK170102 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Direct Sunlight