FDA UDI
In Commercial Distribution
🇺🇸 United States
MTP
DI: 18500042541268
·
Model: 1260
·
MEDICAL TECHNOLOGY PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- MTP
- Primary DI
- 18500042541268
- Version / Model
- 1260
- Catalog Number
- SO1260
- Company Name
- MEDICAL TECHNOLOGY PRODUCTS INC
- Labeler DUNS
- 113078885
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-02-16
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 1c2c47c2-9ec7-4aad-a991-0822f1555a89
Device Description
NITRO ADMIN SET
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
- 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 |
|---|---|---|---|---|
| 16631 | Non-absorbing intravenous administration set | A collection of sterile devices designed for the intravenous (IV) administration of solutions and manufactured with low-absorption plastics to avoid partial absorption of the components of the infused solutions. It typically consists of plastic tubes made of or lined with non absorbing plastics [e.g., polyethylene (PE), Teflon], to avoid solution contact with polyvinyl chloride (PVC) components; it also includes a check valve, a roller clamp, a Y-site connector, and Luer adaptors. The set is mainly used in high-flow infusion pumps for administration of solutions containing products (e.g., nitroglycerin) that are absorbed by PVC materials. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18500042541268 | GS1 | ||||
| Unit of Use | 08500042541261 | GS1 |
Customer Contacts
- Phone
- +1(631)285-6640
- [email protected]