FDA UDI
In Commercial Distribution
🇺🇸 United States
ALLEGIANCE
DI: 10885380114472
·
Model: 19510-035
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ALLEGIANCE
- Primary DI
- 10885380114472
- Version / Model
- 19510-035
- Catalog Number
- 19510-035
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-19
- Public Version
- 3
- Public Version Date
- 2018-07-19
- Public Version Status
- Update
- Public Device Record Key
- 3eb6c1e7-2708-472a-9d13-385e0a4a2749
Device Description
Tomac Lukens Tube 8CC, 3 1/4"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| BYZ | TRAP, STERILE SPECIMEN | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38476 | Suction system bottle | A cylindrical sealable container made of glass or plastic (typically chemical resistant) that is used as a component of a suction system, or other system that utilizes suction, for the collection of aspirated waste materials (e.g., blood, bodily fluids, laser plume evacuation gas) and/or body tissue intended for diagnostic/therapeutic purposes (e.g., histological analysis, autologous fat tissue transfer) from a site of operation. It may be used singularly or in a connected series to provide greater capacity, and may be calibrated to facilitate determination of the quantity of its contents. Suction system bottles are not used in conjunction with suction liners. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20885380114479 | GS1 | BOX | 12 | In Commercial Distribution | |
| Primary | 10885380114472 | GS1 | ||||
| Package | 50885380114470 | GS1 | CASE | 4 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 8 | Milliliter | |
| Length | 3.25 | Inch |