FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 10612479260044
·
Model: MC-300
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- McKesson
- Primary DI
- 10612479260044
- Version / Model
- MC-300
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-26
- Public Version
- 1
- Public Version Date
- 2021-06-03
- Public Version Status
- New
- Public Device Record Key
- c4754649-b52b-441a-82ad-ab96c905cb70
Device Description
DECLOGGER, ENT FEED TU 14-16FR Blue 39.5 cm
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58939 | Enteral feeding tube clearing kit | A collection of non-sterile compounds and devices intended to be used to prevent and/or remove, through biochemical action, an enteral formula clog in an in situ enteral feeding tube to maintain luminal patency. It typically includes a combination of enzymes, acids, and buffers (e.g., papain, cellulase, citric acid) and devices (e.g., syringe, tubing) to administer the cocktail into the enteral feeding tube. This is a single-patient device that may be reapplied to the patient for a limited number of times (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20612479260058 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 10612479260044 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905164 | 000 |