FDA UDI
In Commercial Distribution
🇺🇸 United States
EMS Chest Tube Insertion Kit, 24Fr
DI: 00850056748605
·
Model: 4818-32800
·
INTEGRATED MEDCRAFT LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EMS Chest Tube Insertion Kit, 24Fr
- Primary DI
- 00850056748605
- Version / Model
- 4818-32800
- Company Name
- INTEGRATED MEDCRAFT LLC
- Labeler DUNS
- 107523667
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 411afc6a-3efe-4eb5-bff1-0bb78034d50f
Device Description
EMS Chest Tube Insertion Kit, 24Fr, (bilateral) is a comprehensive kit that includes skin prep, a scalpel, surgical instruments, a chest tube, a chest tube valve, and gauze for the placement of bilateral chest tubes.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PYI | Thoracic Catheter Insertion Tray | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61371 | Cardiothoracic surgical procedure kit, non-medicated, single-use | A collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850056748605 | GS1 |