FDA UDI
In Commercial Distribution
🇺🇸 United States
Professional Medical Surgical Supply, Inc. d / b / a International Direct
DI: 00814125010987
·
Model: 600-TKIT-2C
·
PROFESSIONAL MEDICAL-SURGICAL SUPPLY, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Professional Medical Surgical Supply, Inc. d / b / a International Direct
- Primary DI
- 00814125010987
- Version / Model
- 600-TKIT-2C
- Catalog Number
- 600-TKIT-2C
- Company Name
- PROFESSIONAL MEDICAL-SURGICAL SUPPLY, INCORPORATED
- Labeler DUNS
- 042850073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 67ff0a24-e7b5-4070-954a-b70552beb369
Device Description
Compliance Trach Kit w/ Rem Tr, ST
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OGV | Tracheostomy cleaning tray | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14099 | Tracheostomy kit, single-use | A collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10814125010984 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 00814125010987 | GS1 |
Customer Contacts
- Phone
- +1(800)648-5190 ext. 7628
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 55 | Gram |