FDA UDI
In Commercial Distribution
🇺🇸 United States
Eakin
DI: 00768455126804
·
Model: 839263
·
T.G. EAKIN LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Eakin
- Primary DI
- 00768455126804
- Version / Model
- 839263
- Company Name
- T.G. EAKIN LIMITED
- Labeler DUNS
- 229282421
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-05-16
- Public Version
- 1
- Public Version Date
- 2023-05-24
- Public Version Status
- New
- Public Device Record Key
- bf72ca7e-680b-4a3c-8a16-047733a7329a
Device Description
Eakin wound pouch 245mm x 160mm
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
- 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 |
|---|---|---|---|---|
| FON | Bag, Drainage, With Adhesive, Ostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62850 | Wound drainage bag | A plastic pouch designed to be attached with an adhesive to the skin around a large wound or fistula and intended to be used as a receptacle for exudate, blood, or other bodily wastes. It is a one-piece device, supplied in a variety of sizes, with a large-area adhesive flange that can be cut to fit closely around a wound, and which may provide some skin protection. It may have a tubular outlet and be connected to a drain system; it does not include accessory devices (i.e., not a kit). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 80768455126800 | GS1 | ||||
| Primary | 00768455126804 | GS1 |
Customer Contacts
- Phone
- +442891871000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius