FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MPM Medical Supply (Private Label)
DI: 00859013006079
·
Model: LBN-2020
·
MANAN MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- MPM Medical Supply (Private Label)
- Primary DI
- 00859013006079
- Version / Model
- LBN-2020
- Catalog Number
- LBN-2020
- Company Name
- MANAN MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 831737957
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-05
- Public Version
- 5
- Public Version Date
- 2021-07-19
- Public Version Status
- Update
- Public Device Record Key
- 3e8defd7-38c4-432c-b002-ef4ec5cf37a9
- Distribution End Date
- 2019-03-02
Device Description
20 GA X 2" Huber Needle Used Only for Push and Pull of Saline Through Access Port of Lap Band
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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17180 | Subcutaneous infusion/injection port needle | A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20859013006073 | GS1 | Unit Boxes | 10 | Not in Commercial Distribution | 2019-03-02 |
| Package | 10859013006076 | GS1 | Tyvek Pouch | 10 | Not in Commercial Distribution | 2019-03-02 |
| Primary | 00859013006079 | GS1 |
Customer Contacts
- Phone
- 224-625-8331
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K883744 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2 | Inch |