FDA UDI
In Commercial Distribution
🇺🇸 United States
Enteral
DI: 05060590880883
·
Model: DBP-1500
·
GBUK ENTERAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Enteral
- Primary DI
- 05060590880883
- Version / Model
- DBP-1500
- Catalog Number
- DBP-1500
- Company Name
- GBUK ENTERAL LIMITED
- Labeler DUNS
- 216643186
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-14
- Public Version
- 1
- Public Version Date
- 2022-10-24
- Public Version Status
- New
- Public Device Record Key
- 86dc1440-46cd-4614-b8b4-92ea842ef873
Device Description
Enteral, Drainage Bag, PVC, Single Use 1500ml
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| FFD | EVACUATOR, BLADDER, MANUALLY OPERATED | Gastroenterology, Urology | 876.4370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62286 | Gastric drainage/decompression bag | A plastic sac intended to be used to collect stomach contents during gastric drainage/decompression, via an enteral tube (not included), to drain/empty stomach contents (e.g., prior to surgery, as therapy for obstructed bowel). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060590880890 | GS1 | Peel Pack | 50 | In Commercial Distribution | |
| Primary | 05060590880883 | GS1 | ||||
| Package | 05060590880906 | GS1 | Peel Pack | 4 | In Commercial Distribution |