FDA UDI
In Commercial Distribution
🇺🇸 United States
UNOLOK
DI: 08903347003265
·
Model: 21 G X ¾"
·
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- UNOLOK
- Primary DI
- 08903347003265
- Version / Model
- 21 G X ¾"
- Catalog Number
- 00326
- Company Name
- HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
- Labeler DUNS
- 862318107
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-26
- Public Version
- 5
- Public Version Date
- 2020-07-23
- Public Version Status
- Update
- Public Device Record Key
- 19f0c502-6cce-41c6-baea-5191f64d658e
Device Description
UNOLOK Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 12" TUBE MYCO RE-ORDER # 7001-21
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
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FOZ | Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58490 | Venous butterfly needle/set | An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08903347003265 | GS1 | ||||
| Package | 18903347003262 | GS1 | BOX | 100 | In Commercial Distribution | |
| Package | 28903347003269 | GS1 | CARTON | 10 | In Commercial Distribution | |
| Package | 58903347003260 | GS1 | PALLET | 18 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953252 | 000 |