FDA UDI
In Commercial Distribution
🇺🇸 United States
LOR 10ml
DI: 14048223012519
·
Model: 0001151-45
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- LOR 10ml
- Primary DI
- 14048223012519
- Version / Model
- 0001151-45
- Catalog Number
- 0001151-45
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-29
- Public Version
- 4
- Public Version Date
- 2021-02-24
- Public Version Status
- Update
- Public Device Record Key
- 3ca55f82-49b8-4d31-bf95-e96994562084
- Distribution End Date
- 2025-03-15
Device Description
LOR 10ml Loss of resistance Syringe, sterile
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
- 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 |
|---|---|---|---|---|
| CAZ | Anesthesia conduction kit | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44884 | Low-resistance epidural syringe | A low-friction glass or plastic barrel (cylinder) with plunger intended to be used with a needle typically to locate the epidural space. The user advances the needle until a loss of resistance (LOR) is sensed in the plunger, indicating entry into the epidural space. The syringe may then be disconnected to allow the introduction of a catheter through the needle for diagnostic or therapeutic intervention. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14048223012519 | GS1 | ||||
| Unit of Use | 04048223012512 | GS1 |
Customer Contacts
- Phone
- +1(888)972-5865
- [email protected]