FDA UDI
In Commercial Distribution
🇺🇸 United States
GABARITH™ PMSET 1DT-XX
DI: 00886333620029
·
Model: 682002
·
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GABARITH™ PMSET 1DT-XX
- Primary DI
- 00886333620029
- Version / Model
- 682002
- Catalog Number
- 682002
- Company Name
- ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
- Labeler DUNS
- 595138793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-25
- Public Version
- 3
- Public Version Date
- 2018-06-11
- Public Version Status
- Update
- Public Device Record Key
- f170abf6-67cb-4e44-a465-36d0c35c3d66
Device Description
60 drops, 60" tube length AdSet connected with a 3cc transducer and a 50" & 10" pressure Tubings. It also includes a separately packed 2x male protective caps.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35927 | Invasive-pressure external transducer, single-use | A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50886333620024 | GS1 | Tyvek Pouch | 50 | In Commercial Distribution | |
| Primary | 00886333620029 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3cc transducer |