FDA UDI
In Commercial Distribution
🇺🇸 United States
Biotronix Healthcare
DI: 00850005165286
·
Model: GEED53007
·
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Biotronix Healthcare
- Primary DI
- 00850005165286
- Version / Model
- GEED53007
- Catalog Number
- GEED53007
- Company Name
- BIOTRONIX HEALTHCARE INDUSTRIES, INC.
- Labeler DUNS
- 065762392
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-05
- Public Version
- 3
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- 38b020cb-09c3-4b2f-ad3b-25c3c4a4f5eb
Device Description
Enteral Delivery Gravity Bag Set w/ ENFit™* 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
- 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
- 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 |
|---|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60445 | Enteral feeding kit, adult/paediatric, non-sterile | A collection of non-sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850005165283 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 00850005165286 | GS1 |
Customer Contacts
- Phone
- 786-473-9436
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181276 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Enteral Delivery Gravity Bag Set w/ ENFit™* Connector |