FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 Tracheostomy Gauze Sponges, Sterile
DI: 00840117340244
·
Model: 35051
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
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Basic Information
- Brand Name
- Resp-O2 Tracheostomy Gauze Sponges, Sterile
- Primary DI
- 00840117340244
- Version / Model
- 35051
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-05-02
- Public Version
- 3
- Public Version Date
- 2024-11-21
- Public Version Status
- Update
- Public Device Record Key
- 14ec36d4-8072-401d-97d7-e8b7f5899cc3
Device Description
STERILE-EO , 100% Cotton, 4" x 4", 12-Ply
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15624 | Tracheostomy tube dressing | A pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00840117322653 | GS1 | ||||
| Primary | 00840117340244 | GS1 | ||||
| Package | 00840117309852 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 00840117340251 | GS1 | Box | 50 | In Commercial Distribution |