FDA UDI
In Commercial Distribution
🇺🇸 United States
Devon
DI: 30884527015829
·
Model: 31142667
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Devon
- Primary DI
- 30884527015829
- Version / Model
- 31142667
- Catalog Number
- 31142667
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-29
- Public Version
- 2
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- 5991a642-123a-4a7e-9385-93a0208a7a4c
Device Description
Tube Holder,Removable Touch Fasten Strap
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGZ | ACCESSORIES, CATHETER | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61111 | Intracranial catheter holder | A small, sterile device designed to secure an intracranial catheter (e.g., intracerebral sensor catheter, intracerebral infusion/drainage catheter, epidural sensor catheter) to the skin; it may also be used as a marker for the planned depth of the catheter insertion. It typically has a gripping mechanism which creates a right angle bend in the tube, and is intended to be held in place with sutures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884527015825 | GS1 | CASE | 100 | In Commercial Distribution | |
| Primary | 30884527015829 | GS1 | ||||
| Package | 20884527015822 | GS1 | PACK_OR_INNER_PACK | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;