FDA UDI
In Commercial Distribution
🇺🇸 United States
QUICK-DRAW HEPARIN ADAPTER
DI: 30857182006099
·
Model: 15-980
·
Innovative Medical Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- QUICK-DRAW HEPARIN ADAPTER
- Primary DI
- 30857182006099
- Version / Model
- 15-980
- Company Name
- Innovative Medical Technologies, Inc.
- Labeler DUNS
- 792740578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-08-05
- Public Version
- 5
- Public Version Date
- 2025-05-15
- Public Version Status
- Update
- Public Device Record Key
- 669b14f2-677b-4142-b962-5d336f1b1bb0
Device Description
QUICK-DRAW HEPARIN ADAPTER FOR USE WITH INNOVAC
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
- 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 |
|---|---|---|---|---|
| GIO | Tube, Collection, Capillary Blood | Hematology | 864.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58154 | Capillary blood transfer tube IVD, EDTA | A non-sterile glass or plastic capillary blood transfer tube coated internally with the anticoagulant ethylenediaminetetraacetic acid (EDTA), and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50857182006093 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 30857182006099 | GS1 | ||||
| Unit of Use | 00857182006098 | GS1 |
Customer Contacts
- Phone
- 866-560-1820
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972969 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius