FDA UDI
In Commercial Distribution
🇺🇸 United States
Argyle
DI: 10192253012736
·
Model: 8888265314
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Argyle
- Primary DI
- 10192253012736
- Version / Model
- 8888265314
- Catalog Number
- 8888265314
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-20
- Public Version
- 1
- Public Version Date
- 2024-06-28
- Public Version Status
- New
- Public Device Record Key
- 758d414c-f952-4322-8009-57cffee899fb
Device Description
Stomach Tube Levin Type
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRQ | TUBE, LEVINE | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35415 | Nasogastric decompression tube | A sterile, thin, flexible, hollow, single- or double-lumen cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily to reduce the pressure within the gastrointestinal tract, typically aided by connection to an intermittent suction system, that may follow presurgical or postsurgical intestinal occlusion. It may also be used for the delivery of fluids (for irrigation, enteral feeding, and medication administration) typically for the period that gastric decompression is required. This device may be referred to as a nasogastric sump tube or a gastrointestinal decompression tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253012734 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 10192253012736 | GS1 |