FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Filter Line MG
DI: 00817984010167
·
Model: 0600-MG2407-000
·
MECTRA LABS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Filter Line MG
- Primary DI
- 00817984010167
- Version / Model
- 0600-MG2407-000
- Catalog Number
- 0600-MG2407-000
- Company Name
- MECTRA LABS, INC.
- Labeler DUNS
- 606939072
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-29
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 81e708ef-4935-4cf7-bd71-66bca288ba59
- Distribution End Date
- 2020-01-10
Device Description
Filter Line MG 22MM Connector
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIF | INSUFFLATOR, LAPAROSCOPIC | Obstetrics/Gynecology | 884.1730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60738 | Endoscopic insufflation tubing set, single-use | A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817984010164 | GS1 | Inner pack | 10 | Not in Commercial Distribution | 2020-01-10 |
| Primary | 00817984010167 | GS1 |
Customer Contacts
- Phone
- +1(800)323-3968
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 115 Degrees Fahrenheit