FDA UDI
In Commercial Distribution
🇺🇸 United States
SAFE CLINITUBES D957P-70-70X1
DI: 05700699428981
·
Model: 942-898
·
Radiometer Medical ApS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
250
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Basic Information
- Brand Name
- SAFE CLINITUBES D957P-70-70X1
- Primary DI
- 05700699428981
- Version / Model
- 942-898
- Catalog Number
- 942-898
- Company Name
- Radiometer Medical ApS
- Labeler DUNS
- 308667539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2024-07-01
- Public Version
- 3
- Public Version Date
- 2026-04-01
- Public Version Status
- Update
- Public Device Record Key
- e4089bc0-aa7d-4675-8e16-3711dc641d38
Device Description
D957P-70-70x1 safeCLINITUBES Blood Sampler Multipack with heparinized plastic capillaries and accessories. 70 µL, 1 vial of 250 units. For ABL77
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GIO | TUBE, COLLECTION, CAPILLARY BLOOD | Hematology | 864.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61419 | Capillary blood collection tube IVD, electrolyte-balanced heparin | A non-sterile glass or plastic collection tube containing electrolyte-balanced heparin (anticoagulant), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin, plasma chemistry determinations). It is typically sealed at one or both ends with a putty-like substance following specimen collection. 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 | 55700699428986 | GS1 | ||||
| Primary | 05700699428981 | GS1 |
Customer Contacts
- Phone
- +4538273827
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 32 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Sensitive to light. Store in a dark place