FDA UDI
In Commercial Distribution
🇺🇸 United States
PTS Diagnostics Capillary Tubes
DI: 00381934774015
·
Model: REF 4774
·
POLYMER TECHNOLOGY SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- PTS Diagnostics Capillary Tubes
- Primary DI
- 00381934774015
- Version / Model
- REF 4774
- Catalog Number
- 4774
- Company Name
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Labeler DUNS
- 835772872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-06-16
- Public Version
- 1
- Public Version Date
- 2025-06-24
- Public Version Status
- New
- Public Device Record Key
- 753b28d5-2467-48af-848a-2973d4d2ed54
Device Description
PTS Collect Capillary Tubes are intended to obtain a drop of whole blood from a fingerstick for self-testing. Capillary tubes are single-use only. Do not reuse.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GIO | TUBE, COLLECTION, CAPILLARY BLOOD | Hematology | 864.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35770 | Capillary blood collection tube IVD, no additive | A glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10381934774012 | GS1 | ||||
| Primary | 00381934774015 | GS1 |
Customer Contacts
- Phone
- +1(877)870-5610
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius