FDA UDI
In Commercial Distribution
🇺🇸 United States
AVANOS
DI: 00350770469232
·
Model: 46923
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AVANOS
- Primary DI
- 00350770469232
- Version / Model
- 46923
- Catalog Number
- EES-75
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-17
- Public Version
- 2
- Public Version Date
- 2020-04-03
- Public Version Status
- Update
- Public Device Record Key
- b2a566e9-d01c-4cdd-a867-e8d62fff219a
Device Description
Enteral Drainage Bags
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 | 10350770469239 | GS1 | CS | 10 | In Commercial Distribution | |
| Primary | 00350770469232 | GS1 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]