FDA UDI
In Commercial Distribution
🇺🇸 United States
NerveGuard
DI: 04048223069608
·
Model: 001151-38M
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NerveGuard
- Primary DI
- 04048223069608
- Version / Model
- 001151-38M
- Catalog Number
- 001151-38M
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-30
- Public Version
- 1
- Public Version Date
- 2025-02-07
- Public Version Status
- New
- Public Device Record Key
- 39e95e26-2bdb-469e-8716-6a131f4104b9
Device Description
NerveGuard Injection pressure device for cannulas 18-22G
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
- MR Unsafe
- Direct Marking Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | Anesthesiology | 868.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61722 | Nerve-block injection manometer | A sterile, noninvasive, non-powered (passive) device intended to be connected between a syringe and a nerve-block needle (e.g., fitted to anaesthesia delivery tubing) to indicate injection pressure during administration of local or regional anaesthesia to achieve peripheral nerve blockade. It is intended to provide qualitative feedback (e.g., via a traffic light indicator) to the healthcare professional so that corrective measures can be taken for undesirable pressures (e.g., high injection pressure may indicate undesirable needle tip placement). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04048223049013 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04048223069608 | GS1 |
Customer Contacts
- Phone
- +1 770-493-6832
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170435 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 65 Percent (%) Relative Humidity