FDA UDI
In Commercial Distribution
🇺🇸 United States
Grip-Lok
DI: 10618125192196
·
Model: 3300M-10PK
·
TIDI PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Grip-Lok
- Primary DI
- 10618125192196
- Version / Model
- 3300M-10PK
- Catalog Number
- 3300M-10PK
- Company Name
- TIDI PRODUCTS, LLC
- Labeler DUNS
- 063519193
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-12-02
- Public Version
- 3
- Public Version Date
- 2026-04-22
- Public Version Status
- Update
- Public Device Record Key
- 470ceafd-046c-4bb7-934f-0c139d32a973
Device Description
Medium Universal Securement Device for lines and tubes sized 9 - 24 Fr
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PLI | Gastrointestional Tube Holder | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36053 | Nasogastric tube holder, noninvasive | A small, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. It is typically designed as an adhesive plaster with wings that are attached to the face (e.g., across the bridge of the nose, on the cheeks). It may have a lock-ring or non-adhesive tabs that is/are attached to the nasogastric tube (placed through a nostril and via the oesophagus) to hold it safely and comfortably in place. The lock-ring or tabs can be removed without scissors for easy removal of the tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00618125192199 | GS1 | ||||
| Primary | 10618125192196 | GS1 | ||||
| Previous | 00618125134717 | GS1 |