FDA UDI
In Commercial Distribution
🇺🇸 United States
Argyle
DI: 30884527000092
·
Model: 8886864304
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Argyle
- Primary DI
- 30884527000092
- Version / Model
- 8886864304
- Catalog Number
- 8886864304
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 7
- Public Version Date
- 2020-11-02
- Public Version Status
- Update
- Public Device Record Key
- c9b85327-8435-46e4-bb20-072420ca83e5
Device Description
Luki Tube Specimen Collection Device,8 mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDH | CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36787 | Thoracic suction system | An assembly of devices designed to evacuate large volumes of fluid and/or air accumulated between the lung and chest wall (pleural space) by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system is usually employed following thoracic surgery, traumatic chest wounds, barotrauma, or pleural effusions. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884527000095 | GS1 | CASE | 48 | In Commercial Distribution | |
| Primary | 30884527000092 | GS1 | ||||
| Package | 10884527000098 | GS1 | PACK_OR_INNER_PACK | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.25 | Inch | |
| Total Volume | 8 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;