FDA UDI
In Commercial Distribution
🇺🇸 United States
TRIPLE LINE SET WITH SAFEDRAW(TM)
DI: 00886333679133
·
Model: 687913
·
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TRIPLE LINE SET WITH SAFEDRAW(TM)
- Primary DI
- 00886333679133
- Version / Model
- 687913
- Catalog Number
- 687913
- 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
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 191e7480-31b0-4400-9ecc-d7638c78f9cd
Device Description
A 3-way 20 drops,60" tubing length each AdSet connected with 3x 3cc transducers at each end. 1 channel is connected with a septum with a 5cc syringe with touchguard stops at 2cc via a 48" & 6" Pressure Tubing & a 12" pressure Tubing from Patient. The other 2 lines connects directly to the 3cc transducer each, a 3-way stopcock and a 6" Pressure Tubing. The 3rd line has an additional 3-Way stopcock to the 6" Pressure Tubing. It includes a separately packed 4xmale & 4xfemale 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 |
|---|---|---|---|---|
| 31336 | Arterial blood sampling kit | A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50886333679138 | GS1 | tyvek bag | 20 | In Commercial Distribution | |
| Primary | 00886333679133 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3 cc transducers |