FDA UDI
In Commercial Distribution
🇺🇸 United States
S-Monovette®-Needle 23Gx1"
DI: 04038917530552
·
Model: 85.1442
·
Sarstedt Aktiengesellschaft & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- S-Monovette®-Needle 23Gx1"
- Primary DI
- 04038917530552
- Version / Model
- 85.1442
- Catalog Number
- 85.1442
- Company Name
- Sarstedt Aktiengesellschaft & Co.KG
- Labeler DUNS
- 388000270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2025-10-22
- Public Version
- 1
- Public Version Date
- 2025-10-30
- Public Version Status
- New
- Public Device Record Key
- 6e028add-02da-4bce-a53b-591fc4c007c7
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35209 | Non-fixed blood collection needle | A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). 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 | 04038917530569 | GS1 | ||||
| Primary | 04038917530552 | GS1 |
Customer Contacts
- Phone
- +1(800)257-5101
- [email protected]