FDA UDI
In Commercial Distribution
🇺🇸 United States
Montgomery DME
DI: 10889483223017
·
Model: 0799
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Montgomery DME
- Primary DI
- 10889483223017
- Version / Model
- 0799
- Catalog Number
- 0799
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-30
- Public Version
- 1
- Public Version Date
- 2026-01-07
- Public Version Status
- New
- Public Device Record Key
- 8edb0606-871f-4fac-bd7c-f47d76283d2d
Device Description
Composite Respiratory Kits, 1 - 0027B, 2 - 0556B, 1 - 1220-0, 1-0485, 1 - 0370, 1 - 0795, 1 - No Smoking Sign
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | 868.5340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62042 | Nebulizing system delivery set, reusable | A collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889483223014 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 10889483223017 | GS1 | ||||
| Previous | 00709078007781 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]