FDA UDI
In Commercial Distribution
🇺🇸 United States
75mm Hemato-clad Heparinized
DI: 00860001024012
·
Model: 1-000-7500-HC
·
DRUMMOND SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- 75mm Hemato-clad Heparinized
- Primary DI
- 00860001024012
- Version / Model
- 1-000-7500-HC
- Catalog Number
- 1-000-7500-HC/5
- Company Name
- DRUMMOND SCIENTIFIC COMPANY
- Labeler DUNS
- 002354272
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-05-01
- Public Version
- 1
- Public Version Date
- 2019-05-09
- Public Version Status
- New
- Public Device Record Key
- 15de693b-1af0-4748-a253-fe2525230d2e
Device Description
Capillary Tubes
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GHY | HEMATOCRIT, TUBE, RACK, SEALER, HOLDER | Hematology | 864.6400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57891 | Capillary blood collection tube IVD, ammonium heparin | A non-sterile glass or plastic collection tube containing the anticoagulant ammonium heparin, 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 |
|---|---|---|---|---|---|---|
| Primary | 00860001024012 | GS1 | ||||
| Unit of Use | 10860001024019 | GS1 |
Customer Contacts
- Phone
- +1(215)441-6438
- [email protected]