FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MRV6000LD - Therapeutic Phlebotomy Bag w/Needle
DI: 03567051503128
·
Model: MRV
·
MACO PRODUCTIONS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MRV6000LD - Therapeutic Phlebotomy Bag w/Needle
- Primary DI
- 03567051503128
- Version / Model
- MRV
- Catalog Number
- MRV6000LD
- Company Name
- MACO PRODUCTIONS
- Labeler DUNS
- 265492868
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2019-11-04
- Public Version Status
- Update
- Public Device Record Key
- a93ed5a4-c757-4d4d-ba7a-99e108569f7a
- Distribution End Date
- 2019-11-02
Device Description
500 mL Phlebotomy Bag with Needle.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAK | Microfilter, Blood Transfusion | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44037 | Blood donor set, triple-pack | An assembly of sterile devices intended to be used to collect whole blood from a donor and separate the red blood cells and plasma. It includes three containers (flexible bags) ? one or more with anticoagulation solution and/or preservatives for red blood cells, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the red blood cells and plasma are separated, via centrifugation, into separate containers and subsequently tested, stored, and infused from the containers when needed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 13567051503125 | GS1 | Carton | 20 | Not in Commercial Distribution | 2019-11-02 |
| Primary | 03567051503128 | GS1 |
Customer Contacts
- Phone
- 770-270-6867
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK030008 | 0 |