FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Argyle
DI: 10192253041750
·
Model: 140988
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Argyle
- Primary DI
- 10192253041750
- Version / Model
- 140988
- Catalog Number
- 140988
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-24
- Public Version
- 3
- Public Version Date
- 2025-05-08
- Public Version Status
- Update
- Public Device Record Key
- a5bb418b-030d-4d3b-baf2-2c5a69d1e500
- Distribution End Date
- 2025-05-08
Device Description
Argyle Open Suction Mini Tray with Directional Valve 8 Fr/Ch
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GCX | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62853 | Oropharyngeal secretion specimen suction kit | A collection of non-powered devices intended exclusively for professional use to obtain by suction a mucus/sputum specimen from the oropharynx of a neonate for microbiological examination; it might in addition be used to clear mucus from the oropharynx to assist respiration. It consists of a catheter/tube intended to be inserted orally, a piece of suction tubing intended to be attached to an appropriate pump (not included), an empty specimen collection container, and appropriate adapters/lids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253041758 | GS1 | CASE | 100 | Not in Commercial Distribution | 2025-05-08 |
| Primary | 10192253041750 | GS1 |