FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MEDICOM SAFEBASICS
DI: 10686864048463
·
Model: 405
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
8
Basic Information
- Brand Name
- MEDICOM SAFEBASICS
- Primary DI
- 10686864048463
- Version / Model
- 405
- Catalog Number
- 405
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2019-01-13
- Public Version
- 4
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- 77a9533b-b140-42a8-a572-e647f1eac962
- Distribution End Date
- 2024-01-29
Device Description
MEDICOM SAFEBASICS CONFORMING BANDAGES 4 Inch X 4.1 Yard
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MHW | DRESSING, COMPRESSION | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10284 | Pressure bandage, non-latex, single-use | A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864048460 | GS1 | Outer Case | 12 | Not in Commercial Distribution | 2024-01-29 |
| Primary | 10686864048463 | GS1 | ||||
| Unit of Use | 00686864048466 | GS1 |
Customer Contacts
- Phone
- +1(514)636-6262 ext. 2309
- [email protected]
- Phone
- +1(514)636-6262
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4 Inch X 4.1 Yard |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place