FDA UDI
In Commercial Distribution
🇺🇸 United States
PROVIDENCE HOSPITAL - ONE LINE SET
DI: 00886333680757
·
Model: 688075
·
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PROVIDENCE HOSPITAL - ONE LINE SET
- Primary DI
- 00886333680757
- Version / Model
- 688075
- Catalog Number
- 688075
- 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
- b1434ee9-9bbd-498b-972a-cdecbeec9fd4
Device Description
1-way 20 drops, 60" Adset connected with a 3cc Transducer. The blood sampling line has a 24" Small Bore tube , a 1-way stopcock and another 6" small bore tube connect to the Septum Device. The other end of the device connects to a 3-way Red and a 3-way White stopcocks , a 6" Pressure Tubing which cis connected to a 5cc Restricted Syringe with touchguard stops at 3cc.
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 | 50886333680752 | GS1 | tyvek bag | 25 | In Commercial Distribution | |
| Primary | 00886333680757 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3cc transducer |