FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040193140
·
Model: 5705549
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
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Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040193140
- Version / Model
- 5705549
- Catalog Number
- 5705549
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2025-08-26
- Public Version
- 1
- Public Version Date
- 2025-09-03
- Public Version Status
- New
- Public Device Record Key
- 4042c98e-8f4b-42b3-9785-e3951ba35934
Device Description
SCL Home Infusion Port Access Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OXQ | Dressing change tray | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33961 | General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00304040193143 | GS1 | ||||
| Primary | 10304040193140 | GS1 |