FDA UDI
In Commercial Distribution
🇺🇸 United States
QUICK-DRAW EDTA ADAPTER
DI: 30857182006075
·
Model: 15-974
·
INNOVATIVE MEDICAL TECHNOLOGIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- QUICK-DRAW EDTA ADAPTER
- Primary DI
- 30857182006075
- Version / Model
- 15-974
- 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
- 4
- Public Version Date
- 2018-08-09
- Public Version Status
- Update
- Public Device Record Key
- 19403244-39de-4ae8-8ed7-36abea86c1de
Device Description
QUICK-DRAW EDTA 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 |
|---|---|---|---|---|---|---|
| Primary | 30857182006075 | GS1 | ||||
| Unit of Use | 00857182006074 | GS1 | ||||
| Package | 40857182006072 | GS1 | cs | 5 | In Commercial Distribution |
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