FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoVive Safety PEG Kit
DI: 08714729880387
·
Model: M00509000
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EndoVive Safety PEG Kit
- Primary DI
- 08714729880387
- Version / Model
- M00509000
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 38c6e06e-9511-453c-bdf6-2f4f99eb7759
Device Description
Percutaneous Endoscopic Gastrostomy Kit ENFit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| PIF | Gastrointestinal Tubes with Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64463 | Gastrostomy tube kit, medicated | A collection of devices which includes a gastrostomy tube with a pharmaceutical agent intended for short- and/or long-term (= 24 hours) access to the stomach via a gastrostomy. In addition to the gastrostomy tube and a pharmaceutical agent, the kit includes additional invasive devices designed to perform the gastrostomy and/or assist tube introduction (e.g., scalpel, introduction needle, stoma sizer, guidewire, dilator). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08714729880394 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 08714729880387 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6.7 mm Diameter | ||
| Device Size Text, specify | 20 F Diameter |