FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 10885632423710
·
Model: 55807
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Halyard
- Primary DI
- 10885632423710
- Version / Model
- 55807
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-29
- Public Version
- 1
- Public Version Date
- 2025-02-06
- Public Version Status
- New
- Public Device Record Key
- cc4082b6-cd0a-4f4f-8cbe-e213614168a3
Device Description
Intermittent Catheter Pedriatric 12FR 10IN PVC CLEAR CA/600 NOT MADE WITH NATURAL RUBBER LATEX Halyard
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
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZD | Catheter, straight | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34930 | Single-administration urethral drainage/irrigation catheter | A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20885632423717 | GS1 | 6 | In Commercial Distribution | ||
| Package | 30885632423714 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 10885632423710 | GS1 |