FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kendall
DI: 10884521138858
·
Model: 3615C
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- Kendall
- Primary DI
- 10884521138858
- Version / Model
- 3615C
- Catalog Number
- 3615C
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2018-06-29
- Public Version
- 5
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- eb3fb4f3-9ac3-4015-8f7d-1b6c4d2715c4
- Distribution End Date
- 2023-07-01
Device Description
Standard Porous Tape
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape and bandage, adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34832 | Waterproof skin adhesive tape | A long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521138855 | GS1 | CASE | 36 | Not in Commercial Distribution | 2023-07-01 |
| Primary | 10884521138858 | GS1 | ||||
| Unit of Use | 30884521138852 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length,10,Yard; | ||
| Width | 4 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- This side up;