FDA UDI
In Commercial Distribution
🇺🇸 United States
Kangaroo
DI: 10884521212107
·
Model: 765000
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Kangaroo
- Primary DI
- 10884521212107
- Version / Model
- 765000
- Catalog Number
- 765000
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- ae189c21-4ce7-4af0-82d0-ec76a778b64d
- Distribution End Date
- 2025-12-31
Device Description
ENFit Transition Connector
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| PIO | Enteral specific transition connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64469 | ENFit/non-ISO80369-standardized linear connector | A small, non-powered, noninvasive, tubular two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521212107 | GS1 | ||||
| Package | 10884521515635 | GS1 | Pack or Inner Pack | 20 | Not in Commercial Distribution | 2025-12-31 |
| Package | 20884521212104 | GS1 | CASE | 200 | In Commercial Distribution | 2025-12-31 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;AVOID DIRECT SUNLIGHT