FDA UDI
In Commercial Distribution
🇺🇸 United States
Aqua-C Subcutaneous Hydration System
DI: M991HDC27211
·
Model: Aqua-C
·
NORFOLK MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Aqua-C Subcutaneous Hydration System
- Primary DI
- M991HDC27211
- Version / Model
- Aqua-C
- Catalog Number
- HDC2721
- Company Name
- NORFOLK MEDICAL
- Labeler DUNS
- 013861471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 93d4428f-abae-47e9-908e-f3e4cfd7977a
Device Description
27G x 6mm x Aqua-C Subcutaneous Hydration Needle Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M991HDC27212 | HIBCC | Box | 5 | In Commercial Distribution | |
| Primary | M991HDC27211 | HIBCC |
Customer Contacts
- Phone
- +1(847)674-7075 ext. 102
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K870188 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 27 | Gauge |