FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterling Medical Products
DI: 00685404002104
·
Model: IV-1
·
APOLLO MEDICAL PRODUCTS CORP.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sterling Medical Products
- Primary DI
- 00685404002104
- Version / Model
- IV-1
- Company Name
- APOLLO MEDICAL PRODUCTS CORP.
- Labeler DUNS
- 116768422
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-28
- Public Version
- 1
- Public Version Date
- 2020-05-06
- Public Version Status
- New
- Public Device Record Key
- 9d55bf2e-7614-4f41-b22b-8e254ef6f6ba
Device Description
IV Start Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33963 | Peripheral intravenous catheterization support kit | A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10685404002101 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 00685404002104 | GS1 |
Customer Contacts
- Phone
- 815-537-5303
- [email protected]