FDA UDI
In Commercial Distribution
🇺🇸 United States
RELI
DI: 10386120011278
·
Model: 169018 M
·
MYCO MEDICAL SUPPLIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- RELI
- Primary DI
- 10386120011278
- Version / Model
- 169018 M
- Catalog Number
- 169018 M
- Company Name
- MYCO MEDICAL SUPPLIES INC.
- Labeler DUNS
- 879187821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-03-01
- Public Version
- 1
- Public Version Date
- 2022-03-09
- Public Version Status
- New
- Public Device Record Key
- 25fc6b1c-f924-40ef-908f-d592c79a60fc
Device Description
RELI® Blood Collection Tube Holder
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
- Yes
- 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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37566 | Blood collection tube holder, single-use | A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20386120011275 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10386120011278 | GS1 | ||||
| Unit of Use | 00386120011271 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173279 | 000 |