FDA UDI
In Commercial Distribution
🇺🇸 United States
Membrane-Adapter
DI: 04038917085359
·
Model: 14.1112
·
Sarstedt Aktiengesellschaft & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Membrane-Adapter
- Primary DI
- 04038917085359
- Version / Model
- 14.1112
- Catalog Number
- 14.1112
- Company Name
- Sarstedt Aktiengesellschaft & Co.KG
- Labeler DUNS
- 388000270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2020-04-01
- Public Version Status
- Update
- Public Device Record Key
- 7d2b6792-5b02-495c-9b5f-554dfd923fe8
Device Description
Membrane-Adapter
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 |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58147 | Blood collection tube spike syringe adaptor | A syringe transfer device or Luer-system adaptor intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from the blood access device (e.g., blood collection tube holder with needle) into a syringe that utilizes a Luer fitting (e.g., a blood gas syringe). The adaptor is intended to attach to both the blood access device and the syringe, allowing for syringe connection to an otherwise incompatible blood access device; this may reduce the number of venipunctures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04038917004053 | GS1 | 1000 | In Commercial Distribution | ||
| Primary | 04038917085359 | GS1 | ||||
| Unit of Use | 04038917167444 | GS1 |
Customer Contacts
- Phone
- (800)257-5101
- [email protected]