FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE INDUSTRIES, INC.
DI: 10888277367715
·
Model: OR351
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MEDLINE INDUSTRIES, INC.
- Primary DI
- 10888277367715
- Version / Model
- OR351
- Catalog Number
- OR351
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-15
- Public Version
- 2
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- aa74391c-c25d-4b4a-82f1-667450142b00
Device Description
CONNECTOR,SIMS,NON-STERILE
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
- 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 |
|---|---|---|---|---|
| GAZ | TUBING, NONINVASIVE | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37706 | Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30888277367719 | GS1 | BOX | 50 | In Commercial Distribution | |
| Primary | 10888277367715 | GS1 | ||||
| Package | 20888277367712 | GS1 | CASE | 500 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]