FDA UDI
Not in Commercial Distribution
🇺🇸 United States
High Pressure Luer Lock Set, Single Lumen 300mmHg
DI: 00860936000341
·
Model: HLL003
·
THERMEDX, LLC
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- High Pressure Luer Lock Set, Single Lumen 300mmHg
- Primary DI
- 00860936000341
- Version / Model
- HLL003
- Company Name
- THERMEDX, LLC
- Labeler DUNS
- 022465035
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-07-08
- Public Version Status
- Update
- Public Device Record Key
- 1ff34655-34a0-4e50-b4cc-06148d5006c3
- Distribution End Date
- 2018-12-31
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | 880.5725 | 2 |
| HIG | Insufflator, Hysteroscopic | Obstetrics/Gynecology | 884.1700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36122 | Hysteroscopic irrigation/insufflation system | A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20860936000345 | GS1 | Box | 10 | Not in Commercial Distribution | 2018-12-31 |
| Primary | 00860936000341 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 400 | millibar |