FDA UDI
In Commercial Distribution
🇺🇸 United States
SAK1760M
DI: 00886333621774
·
Model: 682177
·
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SAK1760M
- Primary DI
- 00886333621774
- Version / Model
- 682177
- Catalog Number
- 682177
- 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
- 2016-09-30
- Public Version
- 3
- Public Version Date
- 2018-06-11
- Public Version Status
- Update
- Public Device Record Key
- b0df4e1b-0ce3-4188-90f5-5fe0832f6b0b
Device Description
60 drops, 60" tube length AdSet packs together with a Critiflo Dome connected with a Dampling device and a 48" & 12" pressure Tubing and 2x 3-Way White Stopcocks. It includes a separately packed 2x Male protective caps and a Colour Set
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 |
|---|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | Cardiovascular | 870.2850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37257 | Pressure transducer dome, single-use | A sterile plastic housing that connects together with an external pressure transducer (not included),, forming a measuring compartment. The transducer is influenced by the pressure of the medium, e.g., blood directly from a patient, that is channelled into the compartment, thereby creating the signals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50886333621779 | GS1 | Tyvek Bag | 25 | In Commercial Distribution | |
| Primary | 00886333621774 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 60 drops, 60" tube Adset |