FDA UDI
In Commercial Distribution
🇺🇸 United States
Argyle
DI: 10884527000203
·
Model: 8888258608
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Argyle
- Primary DI
- 10884527000203
- Version / Model
- 8888258608
- Catalog Number
- 8888258608
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-27
- Public Version
- 5
- Public Version Date
- 2024-01-25
- Public Version Status
- Update
- Public Device Record Key
- 4fe951e2-902c-4f93-9ed3-84df7ae99d49
Device Description
Suction Catheter with Mucus Trap,20 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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSY | CATHETERS, SUCTION, TRACHEOBRONCHIAL | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58169 | Oral/respiratory tract specimen container IVD, no additive/medium | An empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884527000200 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 10884527000203 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 20 | Milliliter | |
| Catheter Gauge | 14 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;