FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE UNITE
DI: 10888277699137
·
Model: MPN40013
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDLINE UNITE
- Primary DI
- 10888277699137
- Version / Model
- MPN40013
- Catalog Number
- MPN40013
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-21
- Public Version
- 2
- Public Version Date
- 2020-09-07
- Public Version Status
- Update
- Public Device Record Key
- 1d5b5ddb-ad80-4285-8710-05fa9e8e36e5
Device Description
COMPRESSOR/DISTRACTOR
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| HXW | BENDER | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61605 | Oxygen compressor, home-use | A mains electricity (AC-powered) electromechanical device intended to be used in conjunction with a stationary oxygen concentrator to pressurize and fill/refill ambulatory oxygen cylinders with medical oxygen (O2). It is operated by the patient in the home to facilitate mobile oxygen therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888277699137 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]