FDA UDI
In Commercial Distribution
🇺🇸 United States
Ventilation
DI: 04038917085465
·
Model: 14.1148
·
Sarstedt Aktiengesellschaft & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Basic Information
- Brand Name
- Ventilation
- Primary DI
- 04038917085465
- Version / Model
- 14.1148
- Catalog Number
- 14.1148
- Company Name
- Sarstedt Aktiengesellschaft & Co.KG
- Labeler DUNS
- 388000270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- ed6c7c65-940b-4a62-9258-be10976df5a3
Device Description
Ventilation for blood gas Monovette
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
- 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 |
|---|---|---|---|---|
| JRC | Micro Pipette | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57894 | Blood gas syringe IVD, lithium heparin | A sterile glass or plastic syringe, without a pre-attached needle, containing the anticoagulant lithium heparin intended to be used for the collection, and preservation and/or transport, of blood for blood gas determination and/or other investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04038917075312 | GS1 | 1000 | In Commercial Distribution | ||
| Primary | 04038917085465 | GS1 | ||||
| Unit of Use | 04038917167550 | GS1 |
Customer Contacts
- Phone
- (800)257-5101
- [email protected]