FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EXMOOR
DI: 05060180256159
·
Model: E.301
·
EXMOOR PLASTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- EXMOOR
- Primary DI
- 05060180256159
- Version / Model
- E.301
- Catalog Number
- E301
- Company Name
- EXMOOR PLASTICS LIMITED
- Labeler DUNS
- 298725490
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-10
- Public Version
- 4
- Public Version Date
- 2026-03-20
- Public Version Status
- Update
- Public Device Record Key
- 6f8e9e66-c3ab-42b4-8a86-07cc4ec87543
- Distribution End Date
- 2021-11-30
Device Description
Mal Ear Mop
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060180251925 | GS1 | A BOX | 100 | Not in Commercial Distribution | 2021-11-30 |
| Primary | 05060180256159 | GS1 |
Customer Contacts
- Phone
- +441823351040
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry environment. Avoid extremes of temperature and humidity.
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity