FDA UDI
In Commercial Distribution
🇺🇸 United States
GOIO
DI: 17290008325018
·
Model: GOIO
·
WaisMed Ltd
Product Codes
4
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GOIO
- Primary DI
- 17290008325018
- Version / Model
- GOIO
- Company Name
- WaisMed Ltd
- Labeler DUNS
- 514619238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-05
- Public Version
- 4
- Public Version Date
- 2022-02-21
- Public Version Status
- Update
- Public Device Record Key
- 94a5a7db-f176-4199-a627-97b02e046162
Device Description
Intraosseous start kit by PerSys Medical
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
- 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 |
|---|---|---|---|---|
| KMK | Device, Intravascular Catheter Securement | General Hospital | 880.5210 | 1 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | 878.5900 | 1 |
| OJA | Intravenous Extension Tubing Set | General Hospital | 880.5440 | 2 |
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47011 | First aid absorbent pad/bandage | A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device. | No | Active |
| 32172 | Intravenous line stopcock | A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290008325015 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 17290008325018 | GS1 |