FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10884389657690
·
Model: DYK1023785E
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10884389657690
- Version / Model
- DYK1023785E
- Catalog Number
- DYK1023785E
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-02
- Public Version
- 1
- Public Version Date
- 2021-04-12
- Public Version Status
- New
- Public Device Record Key
- 081a62c4-f77b-40a6-8aba-a515ea3ad36c
Device Description
BAG,EMERGENCY TRACH,SCOTT & WH
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OGV | Tracheostomy cleaning tray | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14090 | Tracheostomy care kit, single-use | A collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40884389657691 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10884389657690 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]