FDA UDI
In Commercial Distribution
🇺🇸 United States
Therapak
DI: 00810185250547
·
Model: ACSK37928
·
Therapak LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
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Basic Information
- Brand Name
- Therapak
- Primary DI
- 00810185250547
- Version / Model
- ACSK37928
- Catalog Number
- ACSK37928
- Company Name
- Therapak LLC
- Labeler DUNS
- 791071165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2025-08-11
- Public Version
- 1
- Public Version Date
- 2025-08-19
- Public Version Status
- New
- Public Device Record Key
- b8227f21-c33f-4013-ad83-6b6077f4319b
Device Description
Urine Cytology/FISH Testing Kit (CS/30)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OIE | Urine Collection Kit (Excludes Hiv Testing) | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62773 | General specimen collection kit IVD, clinical | A collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). 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 | 00810185250554 | GS1 | ||||
| Primary | 00810185250547 | GS1 |