FDA UDI
In Commercial Distribution
🇺🇸 United States
PUREPNEUMO Tubing Set
DI: 00817183020813
·
Model: 7-650-01
·
NORTHGATE TECHNOLOGIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PUREPNEUMO Tubing Set
- Primary DI
- 00817183020813
- Version / Model
- 7-650-01
- Company Name
- NORTHGATE TECHNOLOGIES INC.
- Labeler DUNS
- 627969264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-09
- Public Version
- 1
- Public Version Date
- 2024-07-17
- Public Version Status
- New
- Public Device Record Key
- 3297a755-08c8-491f-bdea-253c0fa1fe66
Device Description
Paired Insufflation and TAP Tubing
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
- Yes
- 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 |
|---|---|---|---|---|
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | Obstetrics/Gynecology | 884.1730 | 1 |
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 | 10817183020810 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00817183020813 | GS1 |